risk assessment when pregnant

Check health and safety risks - Managing pregnancy and maternity

• When someone must tell you
• Discrimination

Check health and safety risks

• IVF treatment
• Your employees' rights
• Illness and difficult pregnancy
• Pregnancy-related appointments
• Planning maternity leave
• Returning to work

By law, you must have a general health and safety risk assessment for all employees. This includes considering specific risks for employees of a childbearing age, for example those who could become pregnant, are pregnant and new mothers.

Specific risks to employees of childbearing age could include:

• work-related stress
• lifting and carrying heavy objects
• sitting or standing for long periods of time
• exposure to toxic chemicals and radioactive materials

Carrying out individual risk assessments

You must carry out an individual risk assessment when an employee tells you in writing that:

• they're pregnant
• they've given birth within the last 6 months
• they're breastfeeding

You should review the risk assessment regularly.

Find out more about risk assessments for pregnant workers and new mothers from the Health and Safety Executive

Have regular health and safety discussions

Once you know an employee is pregnant, a new mother or breastfeeding, you should have regular health and safety discussions with them.

You should consider:

• possible risks that may occur at different stages of pregnancy
• medical advice the employee has received
• the type of work they do

Removing and reducing risks

You must temporarily change the employee's working conditions or hours, if both of the following apply:

• the risk assessment or subsequent discussions with the employee show that risks exist
• the risks cannot be reduced or removed

If it's not possible to change working conditions or hours

You must offer other suitable work to the employee. This work must be both:

• at the same rate of pay
• on terms that do not treat the employee any less favourably

Example of agreeing other suitable work

Jean has a factory packing job that involves lifting heavy crates of food.

Jean tells their boss they're pregnant. As heavy lifting may not be safe for Jean to do while pregnant, Jean's boss offers Jean a temporary alternative job until they go on maternity leave. This job was one found to be safe for pregnant employees when the business did its health and safety risk assessment.

This job does involve packing but not heavy lifting. Jean's pay will remain the same. But the job is at a location 30 minutes further away from Jean's home.

Jean lets their boss know that this would mean extra travel time and costs. As things stand, the terms of Jean's job are not as favourable so the organisation could be breaking the law.

After a discussion with HR, Jean's boss tells them that the organisation will pay for the extra travel. Jean's boss also agrees to treat the extra travel time as part of Jean's working time. This way Jean's working day will not be any longer.

As Jean's overall terms will now be as favourable as for Jean's usual job, they are likely to be within the law. Jean accepts this temporary job.

If the employee does not want to do other suitable work

If the employee does not want to do the other suitable work you've offered, it's a good idea to:

• explore with them why they do not want it
• work with them to find something else suitable

For example, if they object because of health or safety reasons, you could involve a health and safety representative (if there is one at your workplace) to help find them appropriate work.

When you might need to suspend the employee on full pay

If the risks cannot be removed or reduced, and you cannot offer suitable other work, you must suspend the employee from work on full pay.

The suspension must last until either:

• their maternity leave begins
• it's safe for them to start work again

You must also give the employee:

• the outcome of the risk assessment
• the reason why the risk could not be removed

If they're self-employed

If you hire someone who's pregnant and self-employed, you're still responsible for their health and safety at work.

It's best to discuss with them what risk assessment they need depending on the job they do.

Find out more about health and safety for self-employed people from the Health and Safety Executive

If they're an agency worker

An agency worker's time off, pay and other rights depends on their employment status .

The worker's recruitment or employment agency is responsible for fulfilling these rights.

You should:

• keep any information you have about their pregnancy confidential – for example, if you find out about it before their agency does
• check that the job is still safe for them to do, and let them and the agency know if it's not

Find out more about rights for agency workers

If you like, you can tell us more about what was useful on this page. We cannot reply – so do not include any personal details, for example your email address or phone number. If you have any questions about your individual circumstances, you can contact the Acas helpline .

• Health & safety

Pregnancy Risk Assessment

First published on Thursday, Sep 22, 2022

Last updated on Wednesday, Jun 19, 2024

In the workplace, there are many health and safety risks which affect new and expectant mothers. Working conditions that are usually considered acceptable, may no longer be during pregnancy or while breastfeeding. There are laws which require employers to protect the health and safety of expectant mothers.

If these laws are breached, you could face hefty compensation claims or worse, be sent to prison if a pregnant worker has an accident.

This guide will explain what a pregnancy risk assessment is, the common risks a mother may face, and the laws protecting pregnant workers.

Risk Assessment for Pregnant Workers and New Mothers

By law, you should assess the risks to women of childbearing age. An individual risk assessment should also be carried out when they have told you that they:

• Are pregnant.
• Are breastfeeding.
• Have given birth (in the last six months).

Your employee must inform you in writing before you carry out an individual risk assessment.

If you hire someone who's pregnant and self-employed, you're still responsible for their health and safety at work.

To ensure the safety of your pregnant workers, the Health and Safety Executive (HSE) has outlined the following five steps for risk assessments:

• Identify hazards : for example, physical, biological and psychosocial.
• Consider who may be harmed: for example, pregnant workers.
• Evaluate risks and action measures: for example, restrict workers' access to hazardous work areas.
• Review results: for example, if your business has five or more employees, it's a legal requirement to document your findings from the risk assessment.
• Assess the risk assessment: make sure your risk assessments stay relevant.

Complete an Individual Risk Assessment for Your Worker

Once you have been informed in writing by your employee, you can:

• Review your existing risk management and controls for pregnant workers.
• See if there are any conditions or individual circumstances with their pregnancy that could affect their work.
• See if there are any concerns about how the pregnancy could affect their work.
• Talk to their safety representative.

Medical recommendations by their doctor must be taken into account.

Review the Individual Risk Assessment

To ensure safety risks are reduced, you must review your worker's individual risk assessment and make any adjustments when:

• The pregnancy progresses.
• There are significant changes to the worker's job activity or workplace.

Depending on the different stages of the pregnancy, working conditions could present a risk to the mother or child. It may affect a worker's:

• Coordination.
• Movement of speed.

When you have completed your risk assessment, record your findings and share them with your worker and their safety representative.

You should explain to your worker how you'll keep them safe at work.

How to Identify a Risk at Work

If you identify a risk that could cause harm to a pregnant worker or new mothers, you must decide if you can control it. If not, you must do the following:

• Adjust the working conditions to avoid the risk. If this isn't possible, you must:
• Give them suitable alternative work. If this isn't possible because of health and safety reasons, you must:
• Suspend your worker on paid or maternity leave for as long as necessary. If you can't control measures that are put in place, the worker must be suspended on full pay.

The suspension must last until either:

• Their maternity leave begins.
• It's safe for them to start work again.

This should be in line with the Management of Health and Safety at Work Regulations.

What Are Common Health and Safety Risks for a New Mother?

There are a few common risks that a pregnant worker could face, such as:

Their Posture and Position

A new mother may be more prone to injury and may not be apparent until after birth. Pregnant women can experience postural problems during different stages of the process and on their return to work.

You must ensure working conditions or hours are safe for pregnant workers they're not:

• Sitting for long periods.
• Doing any heavy lifting.
• Using a workstation that could cause problems to their posture.

Working Conditions or Hours

Different working routines or hours can play a large effect on the health of pregnant workers, new mothers and even children.

You should assess the risks related to:

• Long hours.
• Shift work.
• Workplace temperature.
• Noise at work .

Physical Injury Risks

Some types of work may carry a risk of physical injury and the consequences for pregnant workers may be more serious.

You should control measures if a worker is:

• Working from a height.
• Working alone.
• At the risk of violence at work.

Exposure to Harmful Substances

Many chemical and biological substances can cause harm to pregnant workers or new mothers, such as:

• Radioactive materials.
• Infectious diseases.
• Chemicals like mercury or pesticides.

These harmful substances can also be passed on to the child during pregnancy or breastfeeding.

What Are the Specific Regulations That Protect the Health and Safety of Expectant Mothers?

Under the Management of Health and Safety at Work Regulations 1999, employers should manage the risks to women of childbearing age, pregnant workers and new mothers.

The Employment Rights Act 1996 states that suitable alternative work should be offered, on the same terms and conditions, before the suspension of work is considered.

If there is no suitable alternative work, the employee should be suspended on full pay for as long as necessary to protect their health and safety. The Workplace (Health, Safety and Welfare) Regulations 1992 says that employers must provide a suitable place for pregnant and breastfeeding workers to rest.

However, the Equality Act 2010, makes it unlawful to dismiss or discriminate against a worker because they're pregnant, a new mother or if they're breastfeeding. Contract, agency and apprentice workers are also protected under the Act. If this law is breached, this could lead to civil liability.

Pregnant Workers Breastfeeding at Work

Pregnant workers or mothers that are breastfeeding need more frequent rest breaks. Agree on frequency and timings so you know when they're resting.

Your suitable area should have:

• Somewhere to lie down.
• Be private so they can breastfeed if they choose to.
• Include somewhere to store milk, for example, a fridge.

Toilets are not suitable for pregnant mothers to rest or lie down.

To make sure the space is safe, you should conduct a risk assessment on your suitable area so that you can eliminate any risks.

Manage Pregnancy Risk Assessment with BrightHR

Reducing the risks for pregnant workers or new mothers is essential. This means a risk assessment should be carried out every time someone is pregnant, breastfeeding or they've given birth in the last six months.

Discuss their health and whether they feel safe at work. This can give you an indication of whether they need to be suspended on maternity leave or whether you can give them more suitable alternative work. If pregnant workers are harmed because of a lack of care, your business could receive a hefty fine or be sent to prison.

BrightHR can help you manage risk assessments with our BrightSafe helpline. Don’t hesitate to call us if you need any help with improving your risk assessment at work. Book a free demo today or give us a call on 0800 783 2806 .

Hanaan Parkinson-Ramsbottom

Health & Safety Advisor

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• Population Health and Prevention
• Women, Infant, and Family Health

Pregnancy Risk Assessment Monitoring System (PRAMS)

The Pregnancy Risk Assessment Monitoring System (PRAMS) is an ongoing, site-specific, population-based surveillance project of the Centers for Disease Control and Prevention (CDC) and health departments. It uses a two-part survey to collect data on maternal attitudes and experiences before, during, and shortly after pregnancy. Survey data has been collected since 1987 and covers approximately 81% of all births in the United States. PRAMS data helps researchers investigate emerging issues and identify ways to reduce health problems for birthing people and their babies.

Between 2021 and 2023, ASTHO convened the Linking PRAMS and Clinical Outcomes Data Multi-Jurisdiction Learning Community supporting 12 states as they build capacity to conduct data linkage activities between PRAMS and other maternal and child clinical outcomes data sets. These linked data sets will inform patient-centered outcomes research and clinical quality improvement initiatives in maternal and child health.

Latest Webinar

Enhancing prams with data linkages: a framework for effective and efficient integration and sustainability.

June 6, 2024

Linking PRAMS with administrative data sources, such as birth certificates, child welfare, and healthcare utilization databases can enable researchers and policymakers to gain an understanding of the factors influencing maternal and child health outcomes. This presentation describes technical resources that can support states in linking PRAMS data with administrative sources.

• Shannon Vance , MPH, Assistant Director, Family and Child Health, ASTHO
• Stephany Strahle , MPH, ASTHO Contractor
• Jared Parrish , PhD, ASTHO Contractor

Previous Webinars By Category

Data linkage 101.

Jan. 12, 2022

In this first session, Russell Kirby, PhD, MS, FACE, provides a high-level overview of the purpose and processes of linking data, as well as factors to consider throughout.

• Russell Kirby is a distinguished university professor, Marrell endowed chair, and strategic area faculty lead for population health science at the College of Public Health, University of South Florida.

Asking the Right Questions

Feb. 16, 2022

In session two, Khaleel Hussaini, PhD, and Milton Kotelchuck, MPH, PhD, discuss how to successfully establish data use agreements and engage partners in the process.

• Khaleel Hussaini is the CDC maternal and child health epidemiology program assignee for the Delaware Division of Public Health.
• Milton Kotelchuck is a professor of Pediatrics at Harvard Medical School, and senior scientist in maternal and child health at both the Center for Child & Adolescent Health Research and Policy at MassGeneral Hospital for Children and the Vincent Obstetrics and Gynecology Department at Massachusetts General Hospital.

Evaluating Your Data Linkages

June 15, 2022

In session five, Cheryl Clark, DrPH, RHIA, discusses connections between data quality and equity, the impacts of linking equity, and ways to ensure and optimize linking equity.

• Cheryl Clark is the Associate Director of Equity, Epidemiology and Evaluation, at the Association of Maternal & Child Health Programs (AMCHP).

Legal Barriers With Data Sharing

March 17, 2022

In session three, Lillian Colasurdo, JD, and Shae Sutton, PhD, discuss national and state legal barriers to data sharing.

• Lillian Colasurdo is the director of public health law and data sharing at the Association of State and Territorials Health Officials.
• Shae Sutton is the senior director of programs at the National Association for Public Health Statistics and Information Systems.

State Share Session

May 19, 2022

In session four, Lizzie Harvey, PhD, MPH, shares successes and challenges with maternal and child health data linkages in Tennessee, while Kara Zivin, PhD, MS, MA, MFA, discusses conducting data linkages of Michigan’s PRAMS and Medicaid data from the perspective of an external partner.

• Lizzie Harvey is the CDC maternal and child health epidemiology program assignee for the Tennessee Department of Health, Division of Family Health and Wellness.
• Kara Zivin is a professor of Psychiatry, Obstetrics, and Gynecology, and Health Management and Policy at the University of Michigan; a research scientist at the Department of Veterans Affairs; and a senior health researcher at Mathematica.

From Benchmarking to Documenting: How NCHS Links and Assesses the Quality of Their Data

Feb. 12, 2023

Lisa Meril, MS, provides an overview of the National Center for Health Statistics Data Linkage program and its end-to-end linkage methodology.

• Lisa Meril is the Chief of the Data Linkage Methodology and Analysis Branch in the Division of Analysis and Epidemiology at the National Center for Health Statistics at the CDC.

Don't Wait, Validate: Estimating Population Outcomes with PRAMS Linked Data

Aug. 7, 2023

Linking PRAMS responses with administrative data is incredibly powerful for exploring population factors associated with various outcomes. However, there are challenges involved: sampling structure, differential response, noncoverage, and small sample sizes can introduce bias. Establishing benchmarks to compare against to validate weighted estimates is critical. Unlike many population-based surveys, PRAMS is directly derived from birth records, which provides a unique validation opportunity.

It’s a Weighty Matter: Exploring PRAMS Weights

Oct. 9, 2023

This session focuses on increasing awareness on how PRAMS weights are constructed, how to properly subset data for weighted analyses, and when health department staff should be worried about over/under estimation. The presenters provide thoughts and methods for checking assumptions of subgroup estimations, potential bias risks, and how re-weighting is sometimes used for smaller subpopulation assessments.

• Jared Parrish, PhD , ASTHO Contractor.
• Phil Hastings, PhD , Founder and Principal, Far Harbor.
• Joe Pirozzolo, PhD , Research Statistician, Far Harbor.

Accelerating Patient Centered Comparative Clinical Effectiveness Research

May 7, 2024

In this webinar, experts discuss work conducted by the Patient-Centered Outcomes Research Institute (PCORI), including the Foundational Expectations for Partnerships framework and PCORNet. Real-world research examples from Florida and Texas were included in the conversation.

• Erin Holve, PhD, MPH, MPP ,Chief Officer, Research Infrastructure & Innovation, Patient-Centered Outcomes Research Institute.
• Nik Koscielniak, PhD, MPH , Program Officer, PCOR Infrastructure and Innovation Program, Patient-Centered Outcomes Research Institute .
• Elizabeth Shenkman, PhD , Chair and Professor, Department of Health Outcomes and Biomedical Informatics, University of Florida.

Additional Resources

Overcoming Common Barriers to Data Linkage

May 4, 2022

This brief examines themes that emerged from conversations with four states about the challenges encountered during data linking activities.

Read the Brief

Leveraging Data Linkage to Address Adverse Childhood Experiences

April 26, 2023

Surveillance data allow public health practitioners and researchers to track changes in the burden of ACEs by collecting data on previous exposure, health conditions that may impact or be impacted by exposure, and other related topics.

Read the Post

Data Strategies to Improve Health Outcomes for Indigenous Communities

June 21, 2023

In this episode, three experts discuss the Federal Advisory Committee on Infant and Maternal Mortality’s most recent report on American Indian and Alaska Native health outcomes and the data-focused recommendations for states and territories.

Listen to the Episode

Linking Datasets to Address Racial Equity in Maternal and Child Health Outcomes

Aug. 1, 2023

This brief examines strategies for promoting racial equity in maternal and infant health through data linkages.

Strengthening Maternal and Infant Health Data in the U.S. Territories

Feb. 19, 2024

This brief highlights the work of Puerto Rico and the Commonwealth of the Northern Mariana Islands and the potential to gain further insights into maternal and infant health outcomes using data linkage methods.

What I Wish I Knew Before Linking Data

May 15, 2024

This conversation between two data linkage experts highlights their lessons learned and recommendations for those seeking to use data linkage projects to examine key public health issues.

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How to complete a pregnancy risk assessment.

As an employer, you have a legal duty to keep employees safe. This includes the safety of female employees of childbearing age and pregnant women and women who have recently given birth. Our report explains why you should conduct a  pregnancy risk assessment , when to complete one and what a pregnancy risk assessment covers in terms of potential risks. We’ll also look at the laws and regulations concerning pregnancy in the workplace and your responsibilities as an employer.

Why should employers conduct a pregnancy risk assessment?

All employers want to keep their employees safe, and a pregnant employee may be more susceptible to injury – either to themselves or to their unborn child. Therefore conducting a pregnancy risk assessment can enable you to put measures in place to ensure their safety.

Reasons for performing a pregnancy risk assessment include:

• It’s your legal duty to protect a pregnant employee and their unborn child.
• It will identify the next steps you need to take to keep a pregnant employee safe.
• It will help avoid claims of discrimination within the workplace.
• It will encourage employee retention.
• It will protect your company from reputational damage.

Legal requirements for pregnancy risk assessments

Employers have a legal duty to keep women of childbearing age and pregnant mothers and their unborn children safe at work under The Management of Health and Safety Work Regulations (1999) (MHSW). The MHSW identifies specific risks that apply from working conditions (such as long hours and stress), physical risks (such as heavy lifting and posture) and biological or chemical risks (such as infectious diseases, lead and toxic materials).

There’s no absolute requirement for you to change the shifts of pregnant women who work at night. However, the Employment Rights Act, 1996 says if a pregnant employee has a medical certificate stating they can no longer work at night, you must suspend them on full pay. You can offer alternative employment on the same terms before considering a suspension.

Discriminating against a pregnant employee would breach The Equality Act (2010) , which says that you should not treat pregnant employees “unfavourably” during the pregnancy and for a period of 26-weeks after they give birth.

The Equality Act covers women who give birth to a living child and if a woman “gives birth to a dead child” when more than 24 weeks of the pregnancy have passed. So, employers may be in breach if they discriminate against someone who has miscarried or experienced a stillbirth.

Breaching The Equality Act could lead to civil liability, risking reputation damage, a fine and a damages award made to the employee.

What is a pregnancy risk assessment?

A pregnancy risk assessment assesses the potential risks within the workplace. Don’t wait until an employee is pregnant to conduct a risk assessment because, by law, employers should include risks to women of childbearing age within any general workplace risk assessment.

However, you should conduct a risk assessment when an employee informs you that they are pregnant in writing. You should review the risk assessment in the second trimester (3-6 months) and a second review in the third trimester (6-9 months). You should also conduct a risk assessment when an employee returns to work from maternity leave.

Employers with over five employees should record any evaluation in writing.

Risks to consider as part of a pregnancy risk assessment

The Health and Safety Executive (HSE) categorises three areas of pregnancy risk:

Working conditions

Physical conditions, biological and chemical hazards.

All aspect of a pregnant employee’s working conditions should be considered including their safety and welfare when working alone, at height, with hazardous material, and equipment including DSE. Working conditions such as the noise, the temperature of the workplace, and vibrations caused by machinery should be considered too.

New and expectant mothers may be vulnerable to stress because of hormonal, psychological and physiological changes around pregnancy. Additional stress may occur if the woman has reason to be anxious about her pregnancy.

This is a broad area that covers:

• Long working hours
• Manual handling (lifting or carrying heavy loads)
• Movement and posture
• Sitting or standing for long periods
• Temperature
• Working at height
• Workstation and posture issues

Workplace hazards in this area can include:

• Carbon monoxide
• Infectious diseases
• Radioactive materials
• Toxic chemicals such as pesticides

How to conduct a pregnancy risk assessment

The law requires employers to protect pregnant employees and new mothers from harm. Risks will vary depending on the working environment and your employee’s role. Some risks will be more evident than others. For example, some employees will handle the related stresses of pregnancy better than others.

As well as a physical risk assessment, you may wish to enter a dialogue with employees. Conducting a pregnancy risk assessment together sets the scene for an open and honest discussion between you. This allows you to ask if there are any conditions or circumstances relating to their situation that may affect their work, or if they have any concerns about continuing their work. You must also take into account any recommendations given by the pregnant employee’s doctor or midwife.

Conducting a pregnancy risk assessment means that employers must:

• Identify what could cause injury or illness within the organisation (hazards).
• Decide how likely it is that these hazards could cause harm and the degree of risk (this may change depending on the stage of pregnancy)
• Take action to eliminate the threat or control the risk if this isn’t possible.

There are various templates available to support employers with conducting pregnancy risk assessments. All incorporate the three steps set out by the HSE. Using an example, we can show how you’d navigate a pregnancy risk assessment with an employee.

Small retail organisation example:

In this example, a small retail business has an employee who usually sits at the till. Here’s how you might conduct a pregnancy risk assessment based on the HSE’s three individual steps.

• Step 1 (risk assessment) – Sitting for long periods increases the risk of thrombosis (clots) for pregnant and non-pregnant staff. However, pregnancy increases the pressure in the veins in your pelvis and legs so pregnant women may be at increased risk.
• Step 2 (likelihood and degree of risk) – Someone whose job is working at checkout has a high probability (likelihood) of sitting for a long time. A blood clot in blood vessels derived from sitting still can lead to a pulmonary embolism, an emergency but rare (degree).
• Step 3 (action to eliminate the risk) – In this example, you could limit the amount of time someone spends at checkout and offer regular breaks to move around. You could invest in a sit/stand desk in a similar instance with an office worker.

Alternative steps for managing risk in pregnancy

You should aim to offer suitable employment on the same terms and conditions where you cannot adjust working conditions.

If that isn’t possible, you should suspend your employee on paid leave to protect the health and safety of her and her child. In addition, employers have a legal duty to revisit, review and revise the general risk assessment if they suspect it is no longer valid or there have been significant changes to anything it relates to (including employees).

Having regular discussions with a new or expectant mother will help you monitor any changes and address any concerns about health and safety.

Where to download a pregnancy risk assessment template

You can download a pregnancy risk assessment toolkit, including a risk assessment template from the Health and Safety Executive (HSE) .

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• ACS AuthorChoice

What to Expect When Expecting in Lab: A Review of Unique Risks and Resources for Pregnant Researchers in the Chemical Laboratory

Mary kate m. lane.

† Department of Chemical and Environmental Engineering, Yale University, New Haven, Connecticut 06511, United States

‡ Center for Green Chemistry and Green Engineering, Yale University, New Haven, Connecticut 06511, United States

Mahlet Garedew

§ School of the Environment, Yale University, New Haven, Connecticut 06511, United States

Emma C. Deary

∥ Department of Anthropology, Wellesley College, Wellesley, Massachusetts 02481, United States

Cherish N. Coleman

⊥ Department of Biology, University of Detroit Mercy, Detroit, Michigan 48221, United States

Melissa M. Ahrens-Víquez

Hanno c. erythropel, julie b. zimmerman, paul t. anastas.

∇ School of Public Health, Yale University, New Haven, Connecticut 06510, United States

Associated Data

Pregnancy presents a unique risk to chemical researchers due to their occupational exposures to chemical, equipment, and physical hazards in chemical research laboratories across science, engineering, and technology disciplines. Understanding “risk” as a function of hazard, exposure, and vulnerability, this review aims to critically examine the state of the science for the risks and associated recommendations (or lack thereof) for pregnant researchers in chemical laboratories (labs). Commonly encountered hazards for pregnant lab workers include chemical hazards (organic solvents, heavy metals, engineered nanomaterials, and endocrine disruptors), radiation hazards (ionizing radiation producing equipment and materials and nonionizing radiation producing equipment), and other hazards related to the lab environment (excessive noise, excessive heat, psychosocial stress, strenuous physical work, and/or abnormal working hours). Lab relevant doses and routes of exposure in the chemical lab environment along with literature and governmental recommendations or resources for exposure mitigation are critically assessed. The specific windows of vulnerability based on stage of pregnancy are described for each hazard, if available. Finally, policy gaps for further scientific research are detailed to enhance future guidance to protect pregnant lab workers.

1. Introduction

There is substantial evidence showing that more diverse teams produce more innovative work and have higher citation rates. 1 − 4 Despite receiving approximately half of the science, technology, engineering, and math (STEM) baccalaureate degrees, women are increasingly underrepresented as career stages advance, with particularly high attrition in the midcareer—a time when many women have children. 3 , 5 For pregnant laboratory (lab) workers, one component of this “leaky pipeline” may result from uncertainty in the risks borne by pregnant researchers among other challenges related to childrearing while working in a research laboratory. This notion is supported by a 2019 study by Cech and Blair-Loy that showed 43% of female scientists left full-time STEM employment after the birth of their first child, as opposed to 23% of male first-time parent scientists and 24% of childless women scientists. 6

While some organizations offer personalized risk assessments for pregnant researchers to inform the development of a safe work plan, this approach has limitations. First, pregnant researchers may not want to disclose their pregnancy until a later stage, leaving the task of identifying and assessing risks to the pregnant researcher themselves. Further, information on reproductive or developmental effects is scattered or opaque for many hazards encountered in a chemical lab setting, including information on permissible exposure levels and methods of gauging one’s actual exposure. For example, the available resources often identify risks (e.g., “solvents”) without much actionable information. 7 This may lead to unintentional exposures to hazardous substances during early pregnancy, which is often a more vulnerable time for miscarriages and birth defects. Further, when pregnant researchers are told that a hazard poses a “minimal” or “small” amount of risk (since it is very rare or unlikely to be able to say something poses “zero” risk), it still leaves a feeling of anxiety or uneasiness about their work. 8 Finally, this creates a situation where each individual is recreating a risk assessment rather than having the benefit of previous efforts to identify and characterize hazards of concern. As such, this review aims to review the potential risks for pregnant researchers in a chemical lab, where a chemical lab is defined as an industry or academic laboratory engaging in primary research in fields like chemistry, engineering, or medicine, but excluding biological work with substances such as pathogens or live organisms. By synthesizing and critically assessing the state of science of lab environment exposures and risks most relevant to embryonal/fetal development and pregnancy outcomes, this manuscript aims at providing resources to pregnant researchers as well as relevant organizations to inform risk management, mitigation, avoidance, and alternatives.

1.1. Risk for Pregnant Researchers

Risk can be expressed conceptually as the following function of three variables, known as “the risk equation”:

where hazard is an inherent property of the substance in question, exposure depends on the time, dose, and type of interaction with the substance, and vulnerability addresses unique timeframes when susceptibility is heightened or reduced ( Figure ​ Figure1 1 ). 9 Accordingly, an individual’s overall risk can be reduced by minimizing any of the three variables by eliminating the intrinsic hazard by working with a safe chemical, 10 limiting exposure through appropriate control measures, or avoiding periods of increased vulnerability (e.g., pregnancy).

Risk associated with chemical laboratory work for pregnant researchers depends on the level of hazard, exposure, and vulnerability, where each exists on a scale that contributes to overall risk. Types of hazards in a chemical lab include chemical and radiation hazards, among others. Main routes of exposure are dermal, oral, and inhalation exposure, along with ambient exposure to hazardous environments such as radiation or sound. A pregnant researcher and their developing fetus can be more or less vulnerable to certain hazards and exposures based on the progression of their pregnancy.

1.1.1. Hazard

Working in a chemical lab can include working with hazardous substances, resulting in associated risks for researchers, particularly those who are pregnant, upon exposure. Commonly encountered hazards include chemical hazards (e.g., organic solvents, heavy metals, engineered nanomaterials, and endocrine disruptors), radiation hazards (e.g., ionizing radiation producing equipment and materials and nonionizing radiation producing equipment), and other hazards related to the lab environment (e.g., excessive noise, excessive heat, psychosocial stress, strenuous physical work, and/or abnormal working hours). Each hazard, and preferably the confluence of the hazards, should be evaluated for the potential to initiate biochemical mechanisms of teratogenicity and other adverse effects. Reducing hazard is the most promising route to ensure low risk, as it is an intrinsic and constant property of chemicals and processes, whereas exposure control can fail and vulnerability is circumstantial. 11 This approach is one of the key pillars of green chemistry which aims to design safer chemicals, materials, and processes by reducing or eliminating the use of hazardous substances altogether. 10 − 12 Therefore, implementing green chemistry practices would directly benefit pregnant researchers in a laboratory setting.

When examining hazards, numerous adverse effects related to reproduction and pregnancy emerge, which can be categorized into several adverse effects with common outcomes ( Table 1 ). While some effects could fall into several categories (for example, low birth weight may be a birth outcome or a neonatal effect), the categories defined in Table 1 will be used. Additionally, while not focused on fertility effects, fertility is closely related to pregnancy and fetal development, meaning that effects on fertility (both male and female) are included when notable. Also, since it would be dangerous and unethical to perform medical studies of hazards directly involving pregnant women, the toxicological literature relies on observational human studies, in vitro human tissue studies, and animal model studies (most commonly mice and rats) to identify adverse effects. Animal studies are of great use in modeling the toxicity of hazards as they allow for precisely controlled studies permitting accurate determination of effects and thorough physical examinations both pre- and postmortem. 13 , 14 While assessing the results from animal studies, it is important to note that these do not necessarily translate to humans due to limitations in detecting certain adverse effects in animal subjects, differences in receptor densities, unexpected human toxicities, and interspecies differences in absorption, distribution, metabolism, and excretion. 13 − 15 Knowing this, it is still common practice to convert doses in animal studies to appropriate human doses, regardless of exposure route, via allometric scaling, a calculation based on the normalization of dose to body mass and surface area. 14 The conversion is most commonly applied by dividing animal “no observed adverse effect level” doses with an animal specific correction factor (e.g., 7.4 for mice, 6.2 for rats; other species available in literature) 14 into human equivalent doses (HEDs). Once the HED is calculated, a safety factor—with the accepted, default safety factor of 10—is included by dividing the HED by the safety factor to reach acceptable starting doses for human exposure where no effect is expected. 14

1.1.2. Exposure

Laboratory exposures for researchers can be divided into chemical and nonchemical in nature. The three main routes of chemical exposure are oral, dermal, and inhalation. 17 , 18 Since chemical laboratories with standard safety procedures typically prohibit food or drink inside the lab and require the use of personal protective equipment (PPE), exposure via oral or dermal routes are anticipated to be minimal. Therefore, inhalation is expected to be the most relevant route of exposure followed by accidental dermal absorption, yet this ultimately depends on specific lab setups and materials used. Other nonchemical exposures include radiation and excessive noise or heat. In situations where hazards cannot be eliminated or substituted—the preferred approach—exposure can be moderated via engineering controls, administrative controls, and PPE controls, in order of decreasing effectiveness. 10 Engineering controls isolate researchers from hazards and include fume hoods, glove boxes, and the enclosing and shielding of radiation producing equipment. Administrative controls alter the procedures in place to become safer, such as changing work schedules or standard operating procedures. PPE is the final safety measure, which may include the use of respirators, special chemical-resistant gloves, and radiation-blocking lead aprons. Minimizing exposure for pregnant researchers may include several or all these controls, but hazard reduction should always be prioritized before exposure control measures are weighed.

Important to note, neonatal exposure of infants to both chemicals and radiation can also occur via breast milk stemming from maternal exposure. 19 , 20 This exposure route is important for breastfeeding researchers to consider. As such, effects from lactation exposure are included when notable but are not the focus of this review.

1.1.3. Vulnerability

Risks stemming from various hazards change over the course of a pregnancy, resulting in varying windows of vulnerability for pregnant researchers. The rapid changes occurring in both maternal and fetal organs over the course of a pregnancy from conception to birth alter the susceptibility to certain hazards and the severity of negative outcomes ( Figure ​ Figure2 2 ). For example, the placenta (technically a fetomaternal organ) alters the transport of some chemical hazards, such that for certain chemicals vulnerability would be greater in the time before placental formation but reduced afterward; a zygote or embryo is more vulnerable than a fetus to radiation hazards, as its lower bodyweight results in higher relative dose and to chemical hazards due to the critical development occurring during those stages; high radiation exposure during the first two weeks after conception is likely to induce a miscarriage, while during organogenesis, the critical period where human organs begin to form, malformations are the more likely outcome. 21

Important phases of maternal and prenatal development along with critical stages for when selected adverse outcomes can occur. 22 − 24 Note: The common convention to track pregnancies is to start from the date of the last menstrual period instead of the date of fertilization (which happens approximately 2 weeks later). The time in pregnancy is used instead of gestational age for ease of application and understanding of results, and any scientific studies that use gestational age will be adjusted by two weeks to follow time in pregnancy based on last menstrual period. Further, gestation in animal models is much shorter than human gestation, so equivalent time in pregnancy will be noted when discussing applicable results. 25

2. Laboratory Chemical Risk

The concern with chemicals and chemical processes toward pregnancy outcomes arises from effects on both maternal and fetal health. Chemicals can impact maternal health via endocrine disruption, hypertension, or deficiencies, among others, and can impact fetal health—both directly and indirectly—via passage through or accumulation in the placenta causing oxidative stress, endocrine disruption, or alterations in gene expression and cell cycles, among many other possible effects. 26 − 29 In the following discussion, both oxidative stress and endocrine disruption are identified frequently as main underlying biochemical mechanisms of teratogenicity from exposure to certain chemicals, as they can interfere with critical developmental signaling and response processes. Oxidative stress occurs when xenobiotics interfere with redox-sensitive signaling pathways. 28 Prompted by reactive oxygen species (ROS) produced by natural electron leakage in mitochondria or various oxidases, redox switching of thiol redox couples tells cells in a developing fetus when to proliferate, when to differentiate, and when to begin apoptosis (programmed cell death). Some chemical hazards also have the potential to produce ROS, which when exposed to a developing fetus, can cause the misregulation of redox couples and incorrect signaling of cell activity. In addition, excess ROS-producing oxidative stress can lead to macromolecule and protein damage, lipid peroxidation, DNA oxidation, and necrosis (unprogrammed or accidental cell death). 28 Endocrine disruption occurs when xenobiotics mimic or interfere with hormone activity in the body. 30 Because endocrine-disrupting chemicals are a class of emerging chemicals of concern due to their effects on reproductive health of the mother, the father, and the fetus, they are discussed in detail as a chemical class of their own in Section 2.4 .

Following an exposure in the lab, one of the most significant concerns for fetal health is whether or not the chemical crosses the placenta to the developing fetus ( Figure ​ Figure3 3 a,b). 31 , 32 When fully formed, the placenta lessens fetal exposure through both retention and detoxification of xenobiotics. However, some xenobiotics have the ability to pass through the placental membranes, similar to nutrients, through three major mechanisms: diffusion, mediated active transport, or vesicular transport ( Figure ​ Figure3 3 c). 31 Diffusion of chemicals from maternal blood into fetal blood can occur either by direct diffusion, where chemicals follow Fick’s law of diffusion and are driven across the placenta and cell membranes through concentration gradients, or passive diffusion following paracellular passage, where chemicals pass through the space between placental cells, and then into fetal blood through passive diffusion. 31 , 32 Diffusion occurs mainly for small, relatively hydrophobic molecules, like respiratory gases and other hydrophobic chemicals. 31 Mediated active transport employs transporter proteins to facilitate the exchange of hydrophilic and charged molecules and has increased kinetics relative to diffusion. 31 For molecules too large to be transported by either diffusion or transporter proteins, vesicular transport through the membrane can occur by endocytosis, where a macromolecule in maternal blood is engulfed in the membrane, which pinches off to form a vesicle that passes through the membrane and subsequently releases the macromolecule into fetal blood. 31 , 33

(a) Basic structure of fetal and maternal organs with (b) showing the structures within the placenta and (c) showing the structure of placental villi and the main mechanisms of transport across the placenta: (1) diffusion, (2) mediated active transport, and (3) vesicular transport. 31 , 32 , 34

2.1. Organic Solvents

2.1.1. hazard.

Organic solvents are mostly carbon-based chemicals that are used ubiquitously in chemical laboratories for various applications including reactions, extractions, separations, cleaning, and more. Organic solvents often top the list of occupational hazards for pregnant researchers, as they tend to be volatile even at room temperature and many are known carcinogens, neurotoxins, and reproductive hazards. 35 “Solvents” as a general hazard are linked to negative reproductive effects like miscarriage, stillbirth, preterm birth, low birth weight, and birth defects in several population-based occupational studies. 7 , 35 As a result, known teratogenic effects in humans tend to rarely be specific to a single solvent, but rather to a mixture (also see Section 5 ). When working with several solvents simultaneously, it is hard to determine which specific solvent was associated with the observed effect in human studies. 36 Therefore, information on specific solvents relies heavily on animal studies as toxicity indicators.

Incorporating both human and animal studies, the Global Harmonization System (GHS) compiles information on reproductive toxicity into classifications based on available evidence, where GHS classification category 1A is a known human reproductive toxicant based on human studies, category 1B is a presumed human reproductive toxicant based on mostly animal studies, and category 2 is a suspected human reproductive toxicant based on limited evidence in either human or animal studies. 16 Table 2 compiles GHS classifications along with additional literature review on adverse reproductive effects for 50 common organic solvents. The 50 listed organic solvents were chosen as they represent the combined list of the top 25 most commonly used organic solvents based on a solvent-usage analysis by Jordan et al. of three journals: Angewandte Chemie (issue 1 in 2019), Organic Process Research and Development (all 2019 issues), and Journal of Medicinal Chemistry (issues 1 and 2 in 2019) along with a few other known problematic solvents 37 representing most solvents a pregnant researcher is likely to encounter. Additional information on other solvents can be accessed in searchable online databases, such as the European Chemicals Agency’s chemical database or the Agency for Toxic Substances and Disease Registry’s toxicological profiles, among others. 17 , 18 , 38 − 41 Notably, many compounds in Table 2 are listed as “not a GHS listed reproductive hazard” ( Table 2 ). This does not mean that they are safe or not reproductive hazards, but rather, that insufficient information is available for classification, and more research is needed to make a determination. 17 , 38 Using the GHS classification and studies showing adverse effects, hazardous solvents can be identified and prioritized for elimination or substitution with potential alternatives in an effort to reduce risk. Recent green chemistry-inspired solvent selection guides that incorporate hazard considerations have been put forward by the ACS Green Chemistry Institute pharmaceutical roundtable and the European public–private partnership, CHEM21, to identify safer alternatives that retain function. 42 , 43

2.1.2. Exposure

Exposure time and concentration are significant in determining risk associated with organic solvent exposure. 53 For example, in a 1967 Russian epidemiologic study focusing on pregnant anesthesiologists exposed to ethyl ether and other agents, 18 out of 31 pregnancies ended in spontaneous abortion, 53 but those with higher exposure (>25 h per week) experienced abnormal pregnancies, while those with lower exposure (<15 h per week) experienced normal pregnancies (this study has limitations in that these women were exposed to different anesthetics and concentrations that may have also contributed to birth outcomes). 53 The Canadian Centre for Occupational Health and Safety, United States Occupational Safety and Health Administration (OSHA), and the United States National Institute for Occupational Safety and Health (NIOSH) have outlined a series of recommendations to minimize exposure to organic solvents, 80 − 82 although these are not specific to pregnant researchers. These recommendations include substitution with less hazardous solvents when possible, using the smallest amount of the solvent when substitution is not available and using solvents in appropriate fume hoods or, if not possible, in other well-ventilated areas to avoid inhalation. 80 − 82 If exposure cannot be avoided, a respirator with an appropriate cartridge for vapors of the organic solvent in question should be worn to protect against accidental inhalation. For some common organic solvents, OSHA has occupational permissible exposure limits for inhalation defined as average parts per million (ppm) concentration in air over an 8 h work day, also called 8 h time-weighted average (TWA). 82 These permissible exposure limits are for the general worker, but can be used as a first step for addressing laboratory inhalation exposure while keeping in mind that the fetus is often more vulnerable. To avoid dermal exposure, researchers should wear the appropriate type of solvent-resistant gloves and protective clothing. Though popular in laboratories, nitrile or latex gloves do not offer effective protection against all solvents. 81 , 83 Nitrile gloves are generally suitable for incidental contact with chemicals, but permeability varies by solvent (e.g., little protection from chlorinated solvents), while latex gloves provide little protection from organic solvents. 81 , 83 NIOSH and OHSA recommend checking the efficacy of the glove against the specific chemical in readily available glove chemical compatibility charts. 81 , 83 Depending on the solvent(s), a combination of several gloves may be necessary. 81 , 83

2.1.3. Vulnerability

Clinical trials and retrospective observational studies conducted thus far on harmful impacts of organic solvent exposure during pregnancy have been limited to understanding overall effects when exposed to organic solvents throughout pregnancy. There are still many unknowns about the specific timeframes when solvents are most problematic to the health of the fetus. 78 , 84 The first trimester represents a critical period in fetal development, suggesting this may be a time to avoid dangerous organic solvents. 36 McMartin et al. observed a statistically significant relationship between exposure to organic solvents in the first trimester of pregnancy and fetal malformation, yet did not specify which solvents in particular are especially hazardous. 78 Thulstrup and Bonde found that there was an increased level of neural tube defects in newborns who were exposed to glycol esters during the first trimester of pregnancy. 85 However, it is important to be mindful of organic solvent exposure throughout the entire pregnancy, as research is still unclear about specific windows of vulnerability for most organic solvents.

2.2. Heavy Metals

2.2.1. hazard.

Metals, in various forms (e.g., elemental, salts, organometallics), are used in chemical laboratories, often as catalysts or reagents. Heavy metals can be defined as metals whose density is five times larger than that of water (i.e., specific gravity > 5), among others, but the designation “heavy metals” is often used as a catch-all term for a dense metal that is toxic at low concentrations, including lighter metals like aluminum (Al), some metalloids like arsenic (As) and nonmetals like selenium (Se), while excluding nontoxic high-density metals like gold (Au). 26 , 86 Some heavy metals such as cobalt (Co), copper (Cu), chromium (Cr), iron (Fe), manganese (Mn), nickel (Ni), selenium, and zinc (Zn) are essential minerals and trace elements that are found naturally in the human body, while others serve no known biological function. Exposure to essential metals in higher than recommended doses can have deleterious health effects including adverse reproductive outcomes, 26 , 27 , 87 while lower than recommended doses can increase risk of negative birth outcomes. 88 The placenta actively transports Cu, Zn, and Fe, such that increasing metal levels in maternal blood also result in higher levels in the fetal blood. 89

Of the heavy metals, arsenic, cadmium (Cd), chromium, lead (Pb), and mercury (Hg) are the most studied due to exposures in residential and occupational settings. 35 , 85 , 90 − 93 Mechanisms of toxicity of heavy-metal exposure include oxidative cell stress (As, Cd, Cr, Pb), neurological damage (Hg, Pb), DNA damage (As, Cd, Cr), altered glucose metabolism (As), altered calcium metabolism (Cd, Pb), and general interference with essential elements inside the body (Cd, Hg). 26 Generally speaking, heavy-metal toxicity depends on aqueous solubility, oxidation state, and bioavailability, all of which depend on the form of metal. 87 For example, mercury in its organic form such as methylmercury (CH 3 Hg + ; as opposed to elemental or salts of mercury) and arsenic as As(III) (as opposed to As(V)) are more soluble and more easily transportable in biological systems leading to greater toxicity concerns. 86 Furthermore, metal ions can interact with sulfhydryl groups found on proteins and enzymes, which can lead to the suppression of antioxidative processes and depletion of thiol-containing oxidants and enzymes, such as glutathione, and can result in the disruption of essential metabolic functions in the mother and/or the fetus. 33 As, Cd, Cr, Pb, and Hg are discussed in more detail below, and Table 3 contains an overview of known adverse reproductive effects for a variety of other heavy metals.

One of the most common global environmental metal contaminants, arsenic is commonly found in two different oxidation states as arsenate (As(V)) and arsenite (As(III)), the latter being the more toxic form and a known carcinogen. 120 Inorganic arsenic takes the forms of oxides, sulfides, and salts of copper, calcium, sodium, and iron, among others; organic arsenic takes the forms of methyl arsenates. 86 Arsenic has been shown to have endocrine disrupting properties in chicken embryos. 94 In humans, arsenic is known to cross the placenta and has been found in fetal tissue. 121 Exposure to arsenic at levels higher than 10 μg/L in drinking water has been linked to an increased risk of spontaneous abortion, while other adverse outcomes such as stillbirths, neonatal death, hypertension during pregnancy, and gestational diabetes have also been reported. 94 , 97 Impaired growth and development including fetal malformation and increased risk of fetal and infant mortality have also been reported due to arsenic exposure. 94 − 96 When arsenic reacts with an acid, it forms a toxic gas arsine (AsH 3 ), a colorless, nonirritating gas. After entering the blood stream via inhalation, it can damage red blood cells and is fatal to adults at high doses (30 min exposure 25–50 ppm). 40 Increased risk of spontaneous abortion in women exposed to arsine in the work place has been reported, though the studies have limitations due to sample size and lack of data about exposure to other chemicals. 40

Cadmium can accumulate in the liver and kidneys, where it has been shown to be highly toxic. 86 , 122 The placenta appears to inhibit cadmium transport into fetal circulation since higher concentrations were reported in the placenta than in cord blood. 33 In fact, cadmium concentrations in the placenta have been shown to be 10 times higher than in maternal blood and 100 times higher than in cord blood, suggesting cadmium accumulation in the placenta. 92 Cadmium can lead to both reproductive and developmental effects on the fetus. Cadmium reproductive toxicity is linked to its endocrine disrupting activity and its effect on hormone production and binding capacity (especially progesterone and leptin). 26 , 94 , 111 , 123 Cadmium is a metalloestrogen, with one study showing that it acts as an estrogen receptor agonist in rats (also see Section 2.4 on endocrine disruptors). 102 While cadmium accumulation in fetal and embryonic cells is limited, it can interfere with DNA and protein synthesis. 27 Exposure to cadmium via injection has been linked to retardation, malformations, and even embryonic death in rats, malformations in hamsters, and retardation and malformations in mice. 27 Further, cadmium concentrations in the placenta, cord blood, and maternal blood have been reported to inversely affect birth weight 98 , 99 and length in humans. 100 , 101

Chromium is found in the environment in all oxidation states between Cr 2+ and Cr 6+ , but the most common forms are trivalent chromium (Cr 3+ ) and hexavalent chromium (Cr 6+ ). Cr 3+ is an essential nutritional supplement and plays an important role in glucose metabolism, 86 yet exposure to excess levels of Cr 3+ can result in toxicity. Cr 6+ is the more toxic form mainly due to its higher cell membrane permeability in comparison to Cr 3+ . 86 Cr 6+ is a strong oxidizing agent, which can form ROS inside cells, causing oxidative stress and DNA and protein damage. 86 In rats, ingestion of Cr 6+ (250, 500, or 750 ppm as potassium dichromate, K 2 Cr 2 O 7 ) three months prior to gestation showed reduced implantation of fertilized eggs (increased resorptions), reduced number of fetuses, and pre- and postimplantation losses. 103 Fetal effects included subdermal hemorrhage on the thorax and abdomen and skeletal abnormalities due to reduced ossification. 103 In humans, exposure to chromium has been linked to congenital malformations, low birth weight, and DNA damage in some studies, while others have not been able to establish such links. 91 , 104 , 124

Fetal lead exposure can be from exogenous sources (i.e., environmental exposure), but also from lead stored in maternal bones from prepregnancy exposures, which can be mobilized due to metabolic changes that take place to compensate for calcium deficiencies during pregnancy. 90 , 92 , 94 , 125 This latter endogenous exposure mechanism could account for 10–88% of lead found in the blood stream of pregnant women and is one of the reasons that lead exposure prior to pregnancy is a major concern (also see Section 5 on the exposome). 90 Once in the maternal blood stream, lead has been reported to be transported across the placenta via active transport 125 or via passive diffusion and can alter calcium-mediated cellular processes in the placenta. 27 Positive correlations between maternal blood concentrations and placenta concentrations have been reported. 92 However, other studies have reported lower lead concentrations in the placenta than in both maternal or cord blood indicating that lead may not accumulate in the placenta and passes through to the fetus. 92 , 126 There are also reports that lead can accumulate in fetal bones and livers at higher concentrations than in maternal tissue. 125 The United States’ Centers for Disease Control and Prevention (CDC) cautions that prenatal exposure to lead in the range of 5–10 μg/dL 109 can result in neurodevelopmental impairment, increased risk of developmental delay, reduced IQ, and behavioral problems later in life. 107 , 110 , 111 Lead-induced malformations have also been reported in animal studies but not in humans. 27 , 104 While the evidence regarding birth outcomes is conflicting, there have been reports that high levels of lead exposure can lead to higher risk of spontaneous abortion, 27 , 102 , 107 miscarriage, stillbirth, preterm delivery, 26 , 113 , 126 low birth weight, reduced sperm count, and prolonged time to pregnancy due to endocrine disrupting properties in humans. 85 , 93 , 108 Studies have also reported reduced maternal fecundity rate with increasing maternal blood lead level (>20 μg/dL). 93

Mercury is the only metal that is liquid at room temperature. In its elemental form, its toxicity stems from the inhalation following evaporation, a vapor that is colorless and odorless; other forms include inorganic and organometallic compounds. Whether or not the placenta accumulates mercury to lessen fetal exposure is conflicting: Some studies describe accumulation of mercury in the placenta, 92 while others have reported 1.5–3× higher mercury levels in cord blood compared to maternal blood. 33 , 90 Mercury mainly targets the brain, kidneys, and liver. Because of its endocrine disrupting properties, mercury can affect reproductive processes and lead to impaired maternal fertility. 102 In humans, methyl mercury has been demonstrated to have inhibitory effects on DNA synthesis of fetal astrocytes. 27 Prenatal exposure to methyl mercury has been linked to cerebral palsy, mental retardation, and various other effects on brain function related to motor function, visual-spatial perception, language attention, and memory even at low level of exposure. 104 Some studies have also linked mercury to spontaneous abortion. 108

2.2.2. Exposure

Modes of exposure to heavy metals are most commonly via ingestion of contaminated food or water, through use of household products or through inhalation or dermal contact either in residential or occupational settings. 33 , 102 For a pregnant researcher, oral exposure routes in the lab are the least likely unless there are circumstances where metals are retained on the skin and subsequently introduced accidentally into consumed food or water. Rather, dermal or inhalational exposure are likely the more common route of exposure in a lab setting. Penetration of metals through the skin from occupational exposure of metals such as chromium, copper, lead, and mercury has been reported. 87 For the inhalation route of exposure, the metal particles are deposited in the mucosa and transferred into the blood stream. 87 Factors such as particle size, shape, hygroscopicity, and surface charge determine where particle deposition in the respiratory tract occurs. 87 Most larger particles will be trapped in the nose, throat, and large bronchi or sediment in the alveoli, while submicron particles can diffuse through these structures. 87 Once deposited, the particles can be absorbed and thus enter the maternal blood stream. Subsequent heavy-metal exposure to the fetus can occur through the amniotic fluid, the placenta, or the umbilical cord. 89 Depending on the mode of exposure, varying effects can be observed. For example, if metals pass through the placenta, the fetus can be exposed to metals directly, resulting in direct effects, while accumulation of certain metals in the placenta can alter the normal functioning of the placenta itself and interfere with transport of essential elements, potentially leading to deleterious effects for the fetus.

As metals are a part of our daily lives and ubiquitous in many industrial processes, workplace guidelines for most heavy metals and allowable limits of exposure, especially for lead, mercury, arsenic, and cadmium, are available and can be easily accessed. The Agency for Toxic Substance and Disease Registry 18 provides information on exposure to various metals and other toxic agents and compiles information on various residential and occupational exposure limits for the general public. Minimal risk level limits for As are below acute oral doses of 0.05 mg/kg/day and chronic oral doses of 0.0003 mg/kg/day. 127 The OSHA 8 h TWA exposure limits for general workplace air quality are 0.01 mg/m 3 of organo-mercury and 0.1 mg/m 3 of Cd fumes and 0.2 mg/m 3 of Cd dust. 82 However, these are exposure limits for the general worker and are thus not specific for pregnant researchers. The only CDC recommendation specifically for pregnant researchers is for monitoring and follow-up testing of maternal blood lead levels when found to be higher than or equal to 5 μg/dL (50 μg/L) to allow for further intervention. 110 Dermal exposure can be reduced through the use of PPE, while protection against inhalation exposure can result from the proper use of a respirator considering the metal itself and the particle sizes (for nano sized metals, see Section 2.3 ).

2.2.3. Vulnerability

Though there is lack of trimester-based studies for many metals, there are studies reporting that the exposure to metal ions during the early gestational period increased the risk of fetus fatality and developmental anomalies. 27 , 102 , 107 In the first 14 weeks of pregnancy, exposure to heavy metals, such as lead and mercury, has been linked to higher rates of spontaneous abortion. 27 , 102 , 107 Lead transfer across the placenta has been shown in human fetuses as early as 14–16 weeks along with increasing concentrations in fetal tissue with advancing gestational age. 125 Further, elevated maternal blood Pb and Mn levels during the second trimester may be a significant risk factor for neural tube defects. 128 It has also been reported that the first, early second, and late third trimester could be heightened windows of vulnerability to vanadium toxicity and could result in fetal growth impairment. 129 In addition, exposure to heavy metals that have endocrine disrupting properties can affect the preconception phase. Snijder et al. have reported that occupational exposure to lead can have adverse effects on human reproduction leading to reduced sperm count in males, prolonged time to pregnancy, and reduced fecundity rate. 93

2.3. Engineered Nanomaterials

2.3.1. hazard.

Engineered nanomaterials (ENMs) are a class of materials with at least one dimension <100 nm that are manufactured and designed (as opposed to naturally or incidentally occurring) for applications due to their high surface area and unique properties when compared to bulk materials of the same chemical composition. 130 ENMs are frequently synthesized and studied in their own right for the development of novel materials as well as for utilization in chemical, biological, and catalytic applications, among others. ENMs are a newer class of materials but are widespread in chemical laboratories, with research interest accelerating since the late 1990s and nanotechnology research initiatives established in almost all industrialized nations by the early 2000s. 130

Since ENMs are an emerging class of materials, pregnancy-related toxicological information is nascent. Existing literature mainly covers animal studies and a few in vitro human placenta studies, 131 , 132 but collective evidence points to occupational exposure to ENMs being hazardous to fetal development and inducing placental stress in certain exposure scenarios. 132 , 133 Due to their nano size, ENMs can cross the placenta, enabling potentially deleterious direct contact with the fetus and internalization in placental and fetal cells. In contrast, this ability has also been identified as medically beneficial and has resulted in proposals for targeted transplacental drug delivery to treat pregnancy complications, prevent preterm birth, and in some cases increase fetal health. 32 , 134 − 136 The mechanism of transplacental passage depends on the size of ENM, with extremely small particles (typically <25 nm) crossing by paracellular passage and larger nanomaterials crossing by vesicular transport ( Figure ​ Figure3 3 ). 32 Many types of ENMs have the ability to create ROS which cause oxidative stress in cells, leading to effects such as cell apoptosis and inflammation. 137 Some ENMs have also recently been identified as endocrine disruptors (also see Section 2.4 ). 109 , 138

It is important to note that ENM toxicological effects (or lack thereof) vary widely based on many factors, complicating concise hazard information or single recommendations for safe work. ENMs encompass an extremely broad and diverse set of material compositions or types (e.g., carbon-based materials: carbon nanotubes, fullerenes, etc.; metal nanoparticles: gold, silver, copper, etc.; metal oxide nanoparticles: titanium dioxide, silica, ceria, iron oxides, etc.) that each have unique characteristics (e.g., size, shape, surface functionality, surface charge, crystallinity, solubility, aggregation behavior, etc.). Changing the material composition or a single characteristic of the same material can alter its properties substantially, including potential fetal toxicity. 139 For example, despite having the exact same chemical formula, titanium dioxide (TiO 2 ) nanoparticles have differing toxicities based on crystalline structure and the subsequent ability to produce more ROS and resulting oxidative stress. 140 Silica (SiO 2 ) nanoparticles showed different effects in mouse models based on size, dose, and surface functionality including fetal resorption (miscarriage) and restricted fetal growth but only at sizes <100 nm, at the highest doses, and without surface functionalization. 137 In several studies, incorporating surface coatings on ENMs was a way to reduce toxic effects; for silica nanoparticles, adding a surface coating of carboxyl or amine groups eliminated detrimental effects. 137 In addition, modifying the surface of single-walled carbon nanotubes with polyethylene glycol significantly reduced their cytotoxicity. 141

Some general conclusions can be drawn, such as that size and surface coating are the most significant factors driving ENM induced embryonic toxicity and ability to cross the placenta and that ROS generating ability, aggregation behavior, and others factors also contribute, yet inconsistently across nanomaterial types. Typically, smaller particles were more toxic than larger particles, but for example, for silver nanoparticles, larger particles were more toxic than smaller ones at the same concentration. 133 Several reviews exist that cover the pregnancy-related health effects of many common ENM compositions and characteristics (reviews with many ENM types; 132 , 133 , 142 reviews with specific ENM composition information: Carbon-based ENMs, 131 platinum nanoparticles, 143 silver nanoparticles, 144 titanium dioxide nanoparticles 140 ), yet the field is continuing to evolve quickly with the introduction of novel ENMs.

2.3.2. Exposure

Safety guidelines for nanomaterials are lagging behind more traditional chemicals for the general researcher, with a 2010 survey of university and public research laboratories worldwide showing 90% of respondents being unaware of local or national regulations for safe handling of nanomaterials and almost three-quarters reporting having little or no awareness of internal or lab scale rules. 145 Since then, the EU and the US have issued guidance on nano safety practices through ECHA 146 and NIOSH, 147 respectively, but recent surveys in other regions continue to show a lack of awareness of nanomaterial-specific safety and health policy plans. 148 , 149 Guidelines on ENM exposure specific to pregnant researchers are further lagging, although the routes of ENMs exposure are well-established including dermal and via inhalation. 145 , 150 There are some studies on dermal exposure, mainly focusing on metal oxide nanoparticles in cosmetics, with the general conclusion that nanoparticles do not pass through human skin immediately or with short duration exposures, but with repeated exposure can penetrate deeper into the skin and become internalized (e.g., 4.7–6.1% 4 mm diameter titania nanoparticle cosmetic applied directly to skin of pigs for 22 days resulted in skin penetration, 60 days of exposure resulted in internalization). 140 , 151 , 152 Therefore, avoidance of skin contact and appropriate PPE are recommended. ENMs in powder form can become aerosolized and may be suspended for extended periods of time, resulting in inhalational exposure. 150 As such, respirators are recommended whenever in an enclosed laboratory space where ENMs are being used. It is also preferable to work with powdered ENMs in special “nano” hoods that are designed to contain ENMs, thereby preventing their circulation in the laboratory atmosphere. 150 A potentially even more protective route is to suspend ENMs in water or solvents to prevent aerosolization altogether.

2.3.3. Vulnerability

There is evidence that both fetal exposure and resulting effects of ENMs are dependent on the gestational stage in pregnancy. Early evidence of this came from Yang et al. who investigated gold nanoparticles injected in pregnant mice at different gestational stages. The study found that at early stages of a pregnancy, gold nanoparticles accumulated at similar concentrations in both extraembryonic tissues and the fetus, while later in a pregnancy after formation of the placenta, gold nanoparticle concentration in the fetus dramatically decreased. 153 However, the reduced exposure did not equate with toxicity outcomes, as there were no observed adverse effects at any of the gold nanoparticle concentrations. 153 Gestation time influenced toxic effects of zinc oxide nanoparticles orally administered in mice: No fetal toxicity was found during early gestation, yet increased toxicity (i.e., decreased fetal viability) during late gestation after organogenesis. 132 , 154 Stapleton reviewed the effects of a range of ENMs focusing on exposures related to gestational time points, specifically at early gestation and midlate gestation (equivalent to before and after approximately 8 weeks of a human pregnancy). 155 While Stapleton concedes that the literature is limited for gestational exposure to ENMs, she identifies the following trends relying on animal studies, mainly mouse models. 155 During early gestation, inhalation exposure to some ENMs increased rates of unsuccessful implantation of embyros. 155 After implantation but still during early gestation, ENM exposure caused effects on maternal vascular development in relation to the placenta and severe effects on fetal development including increased fetal mortality. During midlate gestation, ENM exposure was dependent on the ability to translocate across the placenta, and in cases of ENM accumulation in placental or fetal tissues, increased placental ROS leading to oxidative stress, low birth weight, reduced fetal growth, and malformations were reported. 155

2.4. Endocrine Disruptors and Other Chemicals of Concern

2.4.1. hazard.

Endocrine disruptors (EDCs) can be very broadly defined as exogenous substances or mixtures that interfere with normal, endogenous hormone action and consequently cause adverse health effects in the person exposed, or in their descendants. 156 EDCs can both be man-made or naturally occurring 157 , 158 and can be present in laboratories as chemicals being used in research or being studied. EDC exposure can impact the crucial functions that hormones play in regulating many physiological systems including in the brain, cardiovascular system, thyroid, pancreas, and importantly, the ovaries and uterus in females and testes and prostate in males. 156 , 157 As a result, a wide variety of negative health outcomes have been reported and are the subject of ongoing research including studies into the impacts of EDCs on reproductive health, thyroid-related disorders, hormone-related cancers, bone and metabolic disorders, and others summarized elsewhere. 156 , 157 , 159 Some of the better-studied EDCs include the bisphenol monomers such as bisphenol A (BPA), 159 − 162 phthalate plasticizers, 159 , 161 , 163 , 164 pesticides such as dichloro-diphenyl-trichloroethane (DDT) and atrazine, 159 , 165 , 166 polybrominated diphenyl ether (PBDE) flame retardants, 159 , 167 the environmentally persistent polychlorinated biphenyl (PCB) and dioxins, 159 the antibacterial triclosan, 168 paraben preservatives, 161 heavy metals such as lead, mercury, cadmium, and arsenic 94 (also see Section 2.2 ), and most recently perfluorooctanoic acid (PFOA) and other per- and polyfluorinated substances (PFAS). 159 , 169 Another recent debate revolves around potential endocrine effects of the herbicide glyphosate. 170 Beyond these notorious compounds, there are hundreds of compounds used in applications ranging from pharmaceuticals and personal care products to pesticides, industrial chemicals, metals, as well as naturally occurring compounds that have been identified as EDCs. 159 , 171 − 173 Given the sheer number of compounds that can be classified as EDCs, this review cannot provide a complete overview, but pregnant researchers should be particularly prudent when research is carried out on compounds with known bioactivity or endocrine disrupting ability, such as pharmaceuticals, pesticides, herbicides, fungicides, and others listed previously. This prudence should also extend to laboratory work involving precursors or degradation products of the above-mentioned classes of compounds, as these can be bioactive or endocrine disrupting themselves.

Of particular concern is prenatal exposure to EDCs in utero via transfer from the placenta, 174 , 175 which can impact the crucial development phases of the embryo, often permanently. 30 Animal studies (both mouse and rat) have shown that in utero exposure to EDCs can result in extreme, immediate effects such as pregnancy loss, 176 as well as effects that only become apparent during later stages in life from alterations in the hormonal balance such as early puberty, behavioral changes, altered breast development, and increased susceptibility for mammary cancer in female offspring; and reduced anogenital distance, delayed puberty, decreased fertility, and spermatogenesis in male offspring. 157 Adverse effects can even be passed on to following generations through epigenetic modifications. 157 , 165 , 177 In humans, in utero exposure to the EDC, diethylstilbestrol (DES), which was prescribed to pregnant women in the US until 1971 in the hopes of preventing miscarriages (it was shown that it in fact did not), 178 led to higher incidences of rare cervicogenital cancers, decreased fertility, and early menopause in daughters of women who used DES during pregnancy. 165 , 179

2.4.2. Exposure

Chemical scientists and laboratory workers were among the 16% of jobs identified with probable exposure to endocrine disrupting chemicals based on a job-exposure matrix study of 348 occupations. 180 While exposure is probable, principal exposure in a chemical laboratory setting can be reasonably expected to stem mainly from inhalation, while dermal or oral exposure should play lesser roles when following typical safety protocols, as described earlier. Much of the known effects of EDCs are connected to oral exposure routes (e.g., orally administered DES, plasticizers in food or beverage containers, or EDC contaminated drinking water), and a few studies investigating occupational exposure show low risk of adverse birth outcomes. 181 , 182 For example, a meta-analysis of maternal occupational exposure to EDCs of approximately 134,000 mother-child pairs in Europe showed an association with increased risk of low birth weight when exposed to one or more EDCs, but did not find associations with length of gestation or preterm delivery. 180 The risk of low birth weight increased with exposure scenarios with more types of EDCs, up to four or more EDCs. 180 Another study of over 500 Danish women potentially exposed to EDCs showed no indications of reduced birth weight or increased risk of preterm birth compared to control groups. 182 Although these studies indicate low risk of adverse birth outcomes, due to the known adverse effects of EDCs on reproduction and development during exposure in utero and the lack of long-term results on offspring from occupational exposure, avoidance, substitution, or extreme caution is recommended when working with any known or suspected EDC in a chemical laboratory in general, and particularly during pregnancy.

2.4.3. Vulnerability

Specific vulnerability windows impacting the fetus’ reproductive health are one of the main concerns about prenatal exposure to endocrine disruptors. Experiments with the known antiandrogens vinclozolin and some phthalates (e.g., benzylbutyl phthalate, dibutyl phthalate, di-2-ethly hexyl phthalate, and di-isononyl phthalate) have shown that the most sensitive period for fetal development is around gestational days 14–19 in rats, which corresponds to the “third trimester” of the approximately 21-day long gestational period of rats. 24 , 25 , 164 , 166 Further, exposure to endocrine disruptors can result in permanent detrimental effects from the fetal stage through sexual maturation during puberty. 163 , 183 , 184 Such permanent changes can potentially be quantified following exposure, but may also become apparent only during adulthood. 160 , 185 In contrast, effects from exposure to endocrine disruptors such as BPA during adulthood may be reversible. 160 Nonetheless, endocrine disruptors can not only impact the reproductive health of the child pre- and postnatally, but they can also impact the preconception stage, including the ability of the couple to achieve a pregnancy, with the fertility of both partners potentially affected by endocrine disruptors. 186 − 191 For additional information, the Endocrine Disruption Exchange has an interactive timeline showing critical windows of developmental vulnerability as related to the development of the central nervous system, female and male reproductive systems, the endocrine system, the immune system, and other systems for the following EDCs: bisphenol A, dioxin, phthalates, chlorpyrifos, and PFAS (poly- and perfluoroalkyl substances). 24

3. Laboratory Radiation Risks

During certain tasks in chemical laboratories, pregnant researchers can be exposed to radiation. Radiation hazards include equipment and materials that produce either ionizing or nonionizing radiation ( Figure ​ Figure4 4 ). The following sections discuss these hazards as they relate to laboratory exposure and the potential impacts on pregnancy.

Types of radiation on the electromagnetic spectrum divided between nonionizing and ionizing radiation, alongside particle ionizing radiation. Noted are some common radiation sources, including ones found in chemical laboratories. 192

3.1. Ionizing Radiation Producing Equipment and Materials

3.1.1. hazard.

Ionizing radiation hazards are present in chemical laboratories in the form of equipment and radioactive materials. Common laboratory equipment sources of ionizing radiation in the form of X-rays include X-ray diffraction (XRD), X-ray fluorescence (XRF), X-ray photo spectroscopy (XPS) and electron microscopes (SEM and TEM) in specific X-ray modes. In these instrument, X-rays are produced internally, and especially in older equipment, there is a potential for these to escape through weak points; newer equipment is typically adequately sealed with no X-ray leakage. 193 Electron beam equipment, such as probes and welders, can emit small levels of γ radiation. Furthermore, at larger specialized facilities, linear particle accelerators, ion implanters, cyclotrons, synchrotrons, and other electron ion accelerators can also emit ionizing radiation.

In contrast to equipment that only produces radiation when energized (i.e., turned on), some materials can continually emit ionizing radiation through radioactive decay. 192 , 194 These materials are referred to as radionuclides, such as tritium ( 3 H, often in the form of tritiated water, β emitter), carbon-14 ( 14 C, β emitter), phosphourus-32 ( 32 P, β emitter), sulfur-35 ( 35 S, β emitter), nickel ( 59 Ni, β and γ emitter; 63 Ni, β emitter), iodine-125 ( 125 I, γ emitter), and americium-241 ( 241 Am, α emitter). There are several other radionuclides, but use of these materials often requires special permission from governments and they are not likely to be in the average chemical laboratory. 194 Radioactive compounds are used as tracers or stains in experiments and in trace amounts in equipment, like household smoke detectors containing 241 Am or gas chromatography detectors utilizing 3 H or 63 Ni. 194

Effects of ionizing radiation on humans are relatively well-documented and thoroughly researched with data available from radioactive incidents (e.g., Hiroshima, Nagasaki, Chernobyl, etc.) and medical occupational exposure (e.g., interventional radiology and cardiology), including effects related to pregnant women and embryos/fetuses. 8 , 21 , 195 , 196 Some ionizing radiation exposure can result in harmful effects, most commonly embryo/fetal lethality, organ malformations, intrauterine growth retardation, mental impairments, genetic anomalies, and childhood cancers. 21 , 195 These effects occur because ionizing radiation can cause direct cell and DNA damage. These severe effects are highly dependent on exposure dose and gestational age as explained below. It is also important to note that while for radiation-producing equipment, doses to the fetus are related directly to the exposure level for the mother, exposure to radionuclides is more complex, as these can accumulate in the fetus (including postnatally during breastfeeding), which can lead to higher direct exposure of the fetus than the mother. 21 , 196

3.1.2. Exposure

Exposure to radiation is dose-dependent and expressed in either exposure dose (common unit: Roentgen, R; SI unit: C/kg), absorbed dose (common unit: Rad, rad; SI unit: Gray, Gy), or equivalent dose (common unit: Rem, rem; SI unit: Sievert, Sv). Absorbed dose (Gy) describes the amount of radiation energy absorbed by the mass of tissue regardless of the type of radiation, while equivalent dose (Sv) incorporates weighting factors for each type of radiation (e.g., α-particles ≫ β particles > γ rays) and type of tissue to calculate a full body dose. 21 Exposure recommendations are typically given as an equivalent dose in mSv, while studies typically report absorbed dose in Gy as a threshold dose—the dose level below which no adverse effects were observed.

The United States Nuclear Regulatory Commission recommends that the pregnant worker should not be exposed to more than 5 mSv per pregnancy with a limit of 0.5 mSv/month. 8 The International Commission of Radiological Protection recommends that exposure not exceed 1 mSv during pregnancy, which is consistent with the US National Council on Radiation Protection. 196 Studies show no evidence that embryonal/fetal doses of 0.1 Gy or less (equivalent to 100 mSv for γ radiation and biological tissue) are associated with negative effects, 8 , 21 but there are still many uncertainties about the ramifications of prenatal radiation exposure, which explains the radiation exposure recommendations of <5 mSv total per pregnancy. 21 , 197

Exposure to a pregnant researcher inside a chemical lab is likely no larger than what can reasonably be expected for an occupational or diagnostic radiation professional. For reference, a single, direct chest X-ray is 0.1 mSv; 198 occupational exposure for interventional radiologists with 1 mm-thick lead protection was measured at 0.03 mSv/month; 8 and the self-reported normal background radiation of an XRD lab was 0.0002–0.0005 mSv/hr, resulting in a maximum exposure of 0.12 mSv/month (assuming maximum accumulative exposure for 8 h days for 30 days). 199 A recent review recommended a three-pronged approach to safe work “using dosimetry data as a guide, tailoring use of personal and ancillary lead shielding, and active [laboratory] practices that can minimize occupational dose”. 8 Shielding is often sufficient to keep fetal exposure below dangerous levels and can be achieved through individual or combinations of shielding materials and forms. 8 In addition to wearing appropriate shielding, OSHA guidelines more broadly recommend minimizing the time spent in areas with elevated radiation levels and maximizing the distance from radiation sources. 8 , 194

3.1.3. Vulnerability

Windows of vulnerability for high doses of ionizing radiation are better understood and more clearly defined due to (the unfortunate) availability of data from radioactive incidents. A pregnancy is particularly vulnerable to radiation in the first two weeks after conception when the principal effect of radiation exposure is failure of embryo implantation and early abortion at a threshold dose of 0.1 Gy. 21 , 195 , 200 During the organogenesis period, radiation exposure can cause intrauterine mortality at a threshold dose of 0.1–0.5 Gy and organ malformations at a threshold dose of 0.05–0.5 Gy. 195 Important brain development occurs between 10 and 27 weeks, when increased risk of intrauterine mortality, severe mental retardation, seizures, and reduced IQ can occur at a threshold dose of at least 0.1 Gy. 195 The developing brain gradually becomes less radiosensitive around 18 weeks when the threshold dose increases to 0.3 Gy. 195 After 27 weeks, the central nervous system becomes relatively more radioresistant with no cases of severe mental retardation observed in children from Nagasaki and Hiroshima exposed only after 27 weeks. 21 , 195 , 200 For miscarriage/intrauterine mortality, the threshold dose needed for increased risk rises as pregnancy progresses, where a dose of 0.1 Gy is associated with higher risk in implantation at weeks 2–4, 0.1–0.5 Gy from weeks 5–27, and >1.0 Gy past 27 weeks to full term. 195 Generally speaking, there is little evidence of increased risk from ionizing radiation to pregnant researchers at below these threshold doses. 8 , 21 , 195

3.2. Non-Ionizing Radiation Producing Equipment

3.2.1. hazard.

In chemical laboratories, some distinct nonionizing radiation producing equipment include heat lamps, lasers, and spectroscopy equipment like ultraviolet–visible, Fourier-transform infrared, and nuclear magnetic resonance (NMR). The CDC states that most common nonionizing radiation from radio frequencies (RF) to ultraviolet (see Figure ​ Figure4 4 ) is not considered uniquely hazardous to pregnancies. 7 , 192 The only unique concern is the ability of nonionizing radiation to generate heat. Depending on wavelength, direct exposure to nonionizing radiation can potentially result in an increase of maternal internal body temperature, which can be hazardous to a developing fetus (also see Section 4.2 on heat stress). 7 , 192

Types of nonionizing radiation that pregnant researchers may be in contact with are ultrahigh magnetic fields (UH-MF) coupled with the RF range (see Figure ​ Figure4 4 ) in NMR or MRI and extremely low frequency magnetic fields (ELF-MF) from electronic equipment. UH-MFs are utilized in magnetic resonance equipment like NMR in chemical laboratories and MRI in medical facilities. Although the majority of literature focuses on the safety of a direct MRI scan and MRI occupational exposure for pregnant women rather than NMR, the core technology is the same so comparisons can be drawn. 201 , 202 Both NMRs and MRIs utilize more than one magnetic field to acquire data or images, including a high strength, static field, and a relatively low strength RF field. NMR and MRI machines are often referenced by their static magnetic field strength which, along with the molecule being measured, determine the operating frequency of the RF field used during measurement. Static magnetic field strengths range from 2.3–23.5 T for NMRs and 1.5–10.5 T for MRIs. 202 RF fields are present during the spectroscopy/imaging process and range in frequencies of 10–1000s of MHz and field strengths on the order of 1–100 μT. While the RF field is lower than the static field, its operating frequency causes the potential for maternal heating. However, both animal and human studies on MRIs do not indicate an increased risk of adverse outcomes. In a study on mice exposed to 75 min daily of 1.5 or 7 T UH-MFs (a direct MRI scan) during pregnancy, no effects were observed on pregnancy rate, duration, litter size, malformations, sex distribution, or postpartum death of offspring. 203 A 2020 literature review of pregnant women concluded that “MRI does not pose any known risks to the fetus though longitudinal data are lacking”. 204

Regarding ELF-MFs, there is much debate since a 1979 study showed higher incidences of childhood leukemia in children living in close proximity to power transmission lines, with the hypothesis that it was linked to ELF-MF exposure. 205 , 206 To date, no mechanism has been conclusively identified for if or how ELF-MF nonionizing radiation causes cancer, although it is labeled “possibly carcinogenic” by the WHO’s International Agency for Research on Cancer. 207 Studies into ELF-MF nonionizing radiation and pregnancy have shown varying results, with some indicating increased risk of miscarriage and decreased fetal growth. 205 , 207 , 208 As exposure to ELF-MF occurs in, but is not unique to, chemical laboratories, pregnant researchers should be aware of it and are referred to other references and reviews. 205 , 207 , 208

3.2.2. Exposure

Exposure guidelines do not exist for NMR occupational exposure, but the American College of Radiation guidance document on magnetic resonance safety states that it is permissible for pregnant healthcare practitioners to work in and around MRIs as long as they do not remain within the MRI scanner bore during the data acquisition period. 209 This recommendation stems from the fact that the strength of the static magnetic field fades as one moves farther away from the magnetic source. The strength of magnetic fields is inversely related to distance from the magnetic center cubed (1/ r 3 ). The American College of Radiation also states that research has shown no harmful effects to the fetus from exposure to a magnetic field lower than 3 T. 209 In addition, newer NMR equipment (since 1995) usually integrates active shielding that limits stray magnetic fields, so the rated maximum field of the instrument is likely not the field being experienced in the environment next to the magnet. 202

3.2.3. Vulnerability

To our knowledge, there are no trimester-based studies that directly address magnetic field exposure from NMR. For MRI, nearly all of the reviewed studies considered data from second and third trimesters, most likely due to policies and recommendations against MRI scans in the first trimester. 204 For example, in the UK, it is currently not recommended to collect MRI scans in the first trimester, 201 although it remains unclear what studies are being used to support this recommendation. Interestingly, a small study of women who received an MRI in the first trimester before their pregnancy was known showed no adverse outcomes. 204

4. Laboratory Stressors

Perhaps surprisingly, even the ambient state of some laboratory environments may pose risks that adversely affect pregnancies. Less obvious than chemical or radiation hazards, latent stressors such as excessive noise or heat, strenuous physical work, abnormal experimental schedules, or conventional psychosocial stress, should be mitigated for pregnant researchers.

4.1. Noise Stress

Sonicators, centrifuges, pumps, vacuum systems, and venting liquid nitrogen tanks are often staples in chemical laboratories and may generate dangerous levels of noise. A “loud” environment is defined at 90 dB by OSHA and 85 dB by the American Conference of Governmental Industrial Hygienists as the threshold noise level for an 8 h TWA shift to prevent work-related hearing loss. 210 Since wearing personal protective equipment such as hearing protection does not protect the fetus, noise reduction should be sought via substitution with quieter equipment, installing noise shielding, or other mitigation measures. The fetus’s developing hearing system is more sensitive than a fully developed one, and the fetus has mostly developed ears by week 20 and starts to respond to external sounds by week 24. While the womb does provide some noise shielding mostly to high and medium frequency sounds, it does not provide sufficient protection against excessive noise and leaves the fetus particularly vulnerable to low frequency sounds. Selender et al. performed a population based cohort study that included over 1.4 million births from mothers with occupational exposure to noise at levels <75 dB, between 75 and 85 dB, and >85 dB. 210 This study showed an association between maternal exposures to >85 dB and hearing dysfunction in children, with a stronger association with more days worked in the loud environment, and no association for noise levels below 75 dB. Some limited evidence shows a slightly increased risk of low birth weight or preterm birth at levels exceeding 85 dB, but studies are inconclusive with others showing no increased risk. 35 , 211 , 212 More research is needed to identify an appropriate noise level limit in the 75–85 dB range and to determine whether exposure during early pregnancy is as detrimental as during later stages in the pregnancy after fetal hearing has developed, but reducing the noise level to under 75 dB is advisable based on the available data.

4.2. Heat Stress

Prolonged exposure to hot environments—whether around ovens, reactors, nonionizing radiation producing equipment, or nonair-conditioned laboratories during the summer—can induce heat stress in pregnant researchers who are more vulnerable to heat as their bodies need to work harder to cool down compared to nonpregnant people. 7 According to the CDC, heat stress, defined as any work situation that causes body temperature to exceed 39 °C or 102.2 °F, can lead to heat stroke, exhaustion, or dehydration in mothers and correspondingly has been linked to reproductive issues and birth defects in the fetus. 7 Beyond the recommendation not to exceed a maternal 2 °C body temperature increase, fetal health effects of heat exposure are less defined. A recent review on extreme ambient heat and pregnancy outcomes in studies that combine a population-based approach with geographic temperature data showed that maternal exposures to extreme heat can be associated with preterm birth, low birth weight, stillbirth, and congenital heart defects. 213 Windows of higher vulnerability for preterm birth, low birth weight, and stillbirth, appeared during exposures in the third trimester, while for congenital heart defects, exposures in weeks 2–8 were most important as the fetal heart is developing in this time frame. 213 The review did not identify temperature-related risks on the individual level as many of the evaluated studies defined “extreme heat” as relative to the preceding week’s temperature conditions or relative to geographic location. 213 Therefore, no single recommendation for “acceptable” heat can be made.

4.3. Psychosocial and Physical Stress

Stress related to work, a type of psychosocial stress, can disrupt the endocrine system due to a heightened stress response (often leading to irregular menstrual cycles in women). 35 , 214 Recent evidence suggests psychosocial stress during pregnancy may induce stress responses and affect androgenic activity in the developing fetus, potentially leading to negative birth outcomes including preterm delivery, low birth weight, and spontaneous abortion. 35 , 214 − 217 Reviews on psychosocial stress and pregnancy outcomes examined both acute psychosocial stress (e.g., stress related to an earthquake disaster or the 9/11 terrorist attack) and chronic psychosocial stress (e.g., anxiety, household stress, job stress, among others). 35 , 214 − 217 While for acute stress, some evidence of association with negative birth outcomes was shown, particularly when experienced in the first trimester, literature on chronic psychosocial stress contained conflicting outcomes. There was evidence of a modest association of increased risk for preterm birth and low birth weight, but little evidence of increased risk of spontaneous abortion with some studies showing no associations with chronic stress. 35 , 214 − 217 Chronic stress experienced in the third trimester (week 30) had a higher risk of preterm birth than in the second trimester (week 16). 217 A caveat to these studies is that work-related stress is just one of many stressors, making it difficult to attribute increased risk directly to specific work-related stress.

Physical stress such as heavy physical work, heavy lifting, prolonged standing, and long or irregular work hours contains some risk of undesired birth outcomes and has been reviewed in detail. 35 , 108 , 216 Specifically, heavy physical work, frequent heavy lifting, and prolonged standing have been implicated in low birth weight, preterm birth, and spontaneous abortion, but with only modest risk. 108 , 216 Frequent heavy lifting has been linked to spontaneous abortion and is of particular concern during the third trimester, with increased risk for early uterine contractions and preterm birth. 35 Working in a lab can lead to abnormal hours, and working nights or irregular hours can affect the pregnant researcher’s circadian rhythm and contribute to spontaneous abortions. 35 The study cohorts where these effects were observed were in fields where pregnant women were consistently subjected to heavy physical stress (e.g., nurses lifting and moving patients daily), which may or may not be applicable to pregnant researchers in laboratories.

5. Moving beyond Conventional Risk Assessment

Exposure to endogenous chemicals during pregnancy and lactation is ubiquitous. 218 Research based on representative sampling of the population at large 219 has documented that virtually every pregnant woman in the USA has at least 43 different environmental chemicals in her body and that persistent organic pollutants are found in pregnant and lactating women across the globe. 20 , 220 A report by the US National Cancer Institute found that “to a disturbing extent babies are born ‘pre-polluted’”. 221 However, conventional risk management for pregnant researchers typically entails reviewing anticipated laboratory situations and generating a “safe work” plan. This approach has significant limitations as exposures in lab are compounded by additional exposures over one’s entire lifetime, and fetal windows of vulnerability have yet to be identified for many hazards. As evidenced by this literature review and mentioned elsewhere, 222 , 223 the vast majority of available reproductive and developmental toxicity studies examine single exposures—in both time and hazard—and the resulting adverse effects are often observed in animal models that do not necessarily translate into similar effects in humans. 15 In reality, multiple exposures can occur simultaneously, often with unknown combinatorial effects including antagonistic, additive, or synergistic interactions (“cocktail effects”). 224 For EDCs and neonatal effects specifically, a recent study reported that being exposed to an EDC mixture of four or more versus a single EDC increased risk of low birth weight. 181 Yet, for many emerging contaminants of concern, it is difficult to draw firm inferences at present about issues such as critical dose and the period(s) of greatest vulnerability. 225 These examples emphasize the increasing importance to expand the current state of science as it relates to the toxicological implications of chemical mixtures and windows of vulnerability, especially those related to prenatal exposures.

Efforts to describe one’s complete risk profile have been enhanced with the introduction of the concept of the “exposome,” defined as each person’s unique entire lifetime environmental exposures from conception onward (a complementary concept to each person’s unique genome). 226 The exposome addresses the need to move beyond single exposure-health effect relationships by incorporating the complexity of exposures through time and to mixtures of multiple substances and environmental factors ( Figure ​ Figure5 5 ). Current exposome studies, such as the ongoing Human Early-Life Exposome prospective study, 222 , 223 incorporate many hazards simultaneously, amassing external environmental factors like atmospheric pollutants, noise, temperature, and community features like green spaces with internal environmental exposures like water pollutants, chemicals, and lifestyle choices. These exposures are studied starting from the prenatal period into childhood along with varying health outcomes. 222 , 223 , 227 , 228 While these studies help to understand the effects of prenatal exposure on the pregnant researchers’ developing fetus, a better understanding of pregnant person’s exposome would be important to better assess and predict potential effects on the pregnancy and child health.

Personal identity (including, for example, identifying as black, indigenous, or a person of color (BIPOC) or low socioeconomic status (SE)) can impact each person’s unique exposome, which arises from their specific external, general external, and internal environments, which can lead to health impacts over an entire lifetime of exposures. This review focuses specifically on pregnant lab researchers and potential reproductive and developmental health impacts resulting from exposure via their occupation (e.g., a specific external environment). 222 , 228

Exposome studies have begun to make linkages between specific environmental factors (e.g., workplace), general environmental factors (e.g., social capital, urban environment), and internal factors (e.g., transcriptomics, metabolomics) to inform individual health risk assessments and impact outcomes ( Figure ​ Figure5 5 ). 229 , 230 It is important to note that this review only covers a small portion of specific environmental factors within one’s exposome and that other specific and general environmental as well as individual factors will also impact the course of a pregnancy ( Figure ​ Figure5 5 ). Additionally, the exposome paradigm elevates the importance of intersectionality when considering compounding exposures and increased baseline vulnerabilities related to race, gender, sexual orientation, and socioeconomic status. 227 , 231 For example, it is well established that industrial facilities, sources of external environmental exposure, are historically more likely to be located in minority and/or low income communities, 232 − 234 thereby leading to adverse health and well-being outcomes ( Figure ​ Figure5 5 ). These profound issues of environmental justice have complex interactions with questions related to who is over- and underrepresented as laboratory researchers due to access, opportunities, and wellness warranting further exploration and are worthy of their own study and critical review.

Finally, for many hazards, there is often insufficient information regarding reproductive toxicity and resulting pregnancy outcomes in general, and specific windows of vulnerability in particular. Addressing these presents a significant opportunity for advancing computational toxicology, high-throughput screening, and predictive modeling. As of 2011, the US Environmental Protection Agency’s ToxCast project began profiling the in vitro bioactivity of chemicals to assess pathway-level and cell-based signatures that correlate with observed in vivo toxicity to reveal meaningful mechanistic relationships and providing models to identify chemicals with potential developmental toxicity. 235 While advances in these areas will inform further studies to elucidate risk concerns, the anatomic, physiologic, and pharmacologic complexities of the systems at play as well as the varied potential compensation mechanisms are not yet able to be sufficiently well-modeled to enable a conclusion of safety. 236 However, there remains significant promise of the potential of these advanced techniques to identify stressors of concern from a developmental toxicity perspective as well as generate far more granular data in terms of timing of exposures and windows of vulnerability. Of course, the highest value of this new knowledge will be to inform the design of safer chemicals with reduced or eliminated inherent hazards, thereby reducing or eliminating potential developmental risks to pregnant individuals and their offspring, including lab researchers. 11 , 237 Through the development and implementation of green chemistry, benefits accrue not only to pregnant researchers and their future offspring but also to the broad research community and society at large, the ultimate end users of the discoveries, as well as historically disadvantaged communities in the vicinities of chemical production facilities. Further, safe chemicals and chemical processes will lead to overall gains in public and ecosystem health in support of a more sustainable future.

Biographies

Mary Kate M. Lane : Mary Kate is a graduate student in the Department of Chemical and Environmental Engineering in Yale’s School of Engineering and Applied Sciences and a member of the Center for Green Chemistry and Green Engineering at Yale. She is a National Science Foundation Graduate Research Fellow and an ACS Green Chemistry Institute Joseph Breen Memorial Fellowship recipient. Her research interests include green chemistry, green engineering, application of green solvents to synthesis of nanoparticles, and creating safer and more inclusive laboratory environments.

Mahlet Garedew : Dr. Mahlet Garedew currently manages Air Company’s Princeton R&D laboratory where she oversees R&D efforts for developing heterogeneous catalysts for carbon dioxide conversion to chemicals and fuels. Prior to this role, Mahlet completed a postdoctoral fellowship at the Center for Green Chemistry and Engineering at Yale working on biomass valorization. She is a recipient of the Yale Institute of Biospheric studies Donnelley fellowship and a Yale Bouchet Graduate Honor Society inductee and was selected as one of the 2019 CAS Future Leaders. Her research interests include green chemistry and engineering, biomass valorization, heterogeneous catalysis, electrocatalysis, and CO 2 capture and utilization.

Emma C. Deary : Emma completed her undergraduate degree in anthropology at Wellesley College in 2021 with interests in social and behavioral sciences in public health. She is currently a research assistant in the Department of Psychiatry at Brigham and Women’s Hospital in Boston, MA.

Cherish N. Coleman : Cherish is an alumna of the College of Engineering & Science and the College of Liberal Arts & Education at the University of Detroit Mercy where she received her bachelor’s degrees in biology and psychology in 2021. She was a part of the ReBUILDetroit undergraduate research program funded by the National Institutes of Health and also a proud member of Delta Sigma Theta Sorority, Incorporated. She is currently a Public Health Sanitarian Technician for Oakland County, MI. Her research interests are centered around public health and policy with a focus on health disparities and environmental health.

Melissa M. Ahrens-Víquez : Melissa is a current undergraduate student in the Department of Chemical and Environmental Engineering at Yale University and a student researcher for the Zimmerman Lab. She is a Yale College Dean’s Research Fellowship Awardee as well as a Goizueta Foundation scholarship fund recipient. Her academic interests include green engineering, toxicology, and environmental justice.

Hanno C. Erythropel : Dr. Hanno Erythropel is currently an Associate Research Scientist and Research Manager at the Center for Green Chemistry & Green Engineering at Yale and holds degrees in chemistry and chemical engineering from Carl-von-Ossietzky University Oldenburg (Germany) and McGill University (Canada). His research focuses on the design of sustainable materials and processes based on green chemistry principles in a highly interdisciplinary approach. Examples include the development of highly functional, safe, yet biodegradable plasticizers for brittle polymers such PVC, mild synthetic routes to produce C-glycosides from sugars, and efforts to valorize renewable materials currently considered as “waste” into industrially useful materials.

Julie B. Zimmerman : Dr. Julie Zimmerman is an internationally recognized engineer whose work is focused on advancing innovations in sustainable technologies. Dr. Zimmerman holds joint appointments as a Professor in the Department of Chemical and Environmental Engineering and School of the Environment at Yale University. She serves as the Senior Associate Dean for Academic Affairs at the Environment School and the Deputy Director of the Center for Green Chemistry and Green Engineering at Yale. In February 2020, Dr. Zimmerman was appointed the Editor in Chief of Environmental Science & Technology , the most highly cited journal in the fields of environmental sciences and engineering.

Paul T. Anastas : Prof. Paul T. Anastas holds the Teresa and H. John Heinz III Chair in Chemistry for the Environment at Yale University and is the Founding Director of the Center for Green Chemistry & Green Engineering at Yale. Dr. Anastas has appointments in the School of the Environment, Department of Chemistry, School of Management, School of Public Health, and the School of Engineering and Applied Sciences. Dr. Anastas has published over 150 research papers and 13 books, is known as the ‘Father of Green Chemistry’, and has been internationally recognized for his advancement of the field.

Supporting Information Available

The Supporting Information is available free of charge at https://pubs.acs.org/doi/10.1021/acs.chemrestox.1c00380 .

• A table containing a curated selection of references including excellent reviews and resources for hazards of concern for pregnant researchers in chemical laboratories ( PDF )

This work was supported by the National Science Foundation Graduate Research Fellowship Program (NSF GRFP fellowship no. DGE1752134) and the Summer Research Experience in Environmental Health (SREEH) funded through the National Institutes of Health.

The authors declare no competing financial interest.

Supplementary Material

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Pregnancy Risk Assessment Monitoring System (PRAMS)

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• PRAMS website: https://www.cdc.gov/prams/index.htm

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Peninsula Team , Peninsula Team

Oct 23rd 2023 (Last updated Apr 16th 2024 )

In this guide, we'll discuss pregnancy risk assessments, workplace risks, and measures you can implement to protect pregnant employees and new mothers.

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What is a pregnancy risk assessment?

Are pregnancy risk assessments a legal requirement, who should carry out a pregnancy risk assessment, what are the steps of an individual risk assessment, does an employer have to offer suitable alternative employment, what are the rights of pregnant women and new mothers at work, what is classed as pregnancy and maternity discrimination, what factors should be considered in a pregnancy risk assessment, when should a pregnancy risk assessment be done, how to conduct a pregnancy risk assessment, get expert advice on pregnancy risk assessments from peninsula.

Your workplace will likely employ women of childbearing age at some point. If a staff member becomes pregnant, it’s your legal duty to protect them in the workplace. You can do this by performing a pregnancy risk assessment.

This type of assessment evaluates the risks your workplace poses to pregnant employees. Failure to perform one could mean your business faces serious consequences. These include workplace injury, claims to an employment tribunal, and even reputational damage.

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A pregnancy risk assessment assesses the risks a workplace poses to new - and expectant - mothers. It involves recording present hazards, assessing the likelihood of them causing harm, and implementing safety control measures.

Every employer must comply with the law when performing a workplace risk assessment, especially for pregnant women. It's a vital part of ensuring their Health & Safety in the workplace.

Yes, pregnancy risk assessments are a legal requirement for employers to perform. The Management of Health & Safety At Work Regulations 1999 state that you must also conduct individual risk assessments of your workers' specific needs.

For example, if a pregnant woman is unable to stand for long hours or long periods, or if they need a head rest for their chair. You should also evaluate whether they can still perform their usual workplace duties.

A competent person within your business should carry out a risk assessment for pregnant workers and new mothers. Such persons assist you when reviewing Health & Safety risks in the workplace, by using their skills, knowledge and experience.

When picking a competent person in your workplace, ensure you consider the following questions:

• Do they have the experience required to identify a Health & Safety risk?
• Do they have the knowledge required to manage potential risks?
• Do they know what significant changes need to be made?

If you fail to perform a risk assessment, you could face serious consequences. These consequences vary, but in rare instances, it could result in a pregnancy and maternity discrimination claim to an employment tribunal .

The Health & Safety Executive (HSE) advises you to complete the following steps when performing an individual risk assessment:

• Assess the existing general risk management within your company, as well as the measures in place that currently protect pregnant workers and new mothers.
• Catch up with new mothers and pregnant workers in your workplace. Ask them if they have any conditions or circumstances that might affect their work.
• Discuss the medical recommendations provided by their doctor or midwife regarding their pregnancy.
• Consult with a safety representative or trade union official to review necessary control measures.
• Address their concerns about how work could affect their pregnancy during its different stages.

If you cannot control or remove a risk to a pregnant employee or new mother, you must amend their working conditions or hours to avoid the risk. If that's not possible - according to The Employment Rights Act 1996 - they should be offered suitable alternative work.

Yes, every employer must offer suitable alternative work to pregnant workers and new mothers -  if they're unable to perform their job without risk. The suitable alternative work you provide should include the same terms and conditions as their previous role.

If this isn't possible, your employee should be suspended on full pay. Suspension with full pay should continue for as long as the pregnant employee or new mother needs. Typically, as long as they need to protect themselves and the Health & Safety of their baby.

Pregnant women and new mothers have several Health & Safety rights. Ensure you're aware of them all so you know what they are entitled to. These include:

• Paid time off for antenatal care (this should be the same rate as they are usually paid).
• Maternity leave .
• Maternity leave pay or maternity allowance.
• Protection against unfair treatment, discrimination or dismissal .

Pregnant workers also have the right to take maternity leave early, if the employee is off on sick leave in the four weeks prior to the baby's birth.

Pregnancy and maternity discrimination is any unfair treatment towards a pregnant worker or new mothers. For a behaviour to class as unfair treatment, the pregnant employee or new mother must suffer a disadvantage as a result.

Under the 2010 Equality Act , pregnancy and maternity is a protected characteristic. This means pregnant workers and new mothers (up to six months - or 26 weeks - after they have given birth) are protected from discrimination.

For example, if an employer makes pregnant employees redundant because of pregnancy or pregnancy-related illness. Or if a new mother returns to work and their role has fundamentally changed. This might include their working hours and working conditions (e.g. if they are made to begin night working ).

There are several factors you need to consider in a pregnancy risk assessment. It's best practice to study them all so you know what to include in your workplace risk assessment. Examples of these factors include:

• Personal protective equipment (PPE) : Consider whether pregnant workers or new mothers need extra items of PPE (perhaps they need larger sizes as their pregnancy progresses).
• Hazardous substances or biological agents: You should also evaluate your employee's exposure to hazardous substances. For example, if you work with solvents, acids or alcohols - you should measure the harm they could cause a pregnant woman and her baby.
• Manual handling : It's important to assess whether your employee is carrying, pushing or pulling heavy loads. If so, you will likely need to provide them with suitable alternative work. But this is more relevant to pregnant women than new mothers.
• Access to suitable facilities : You must consider whether employees have access to suitable and adequate facilities. For example, you might have a new mother who breastfeeds and needs a suitable space for her to express milk.

Make sure you monitor these factors as your employee's pregnancy progresses. Circumstances in your workplace might change, which could increase the likelihood of a hazard causing harm.

A pregnancy risk assessment should be done as soon as an employee tells you they are pregnant. For example, when a worker tells you in writing that:

• They've given birth within the last six months.
• They're breastfeeding.

This law applies to permanent, temporary and agency workers . Ensure you review the risk assessment regularly in case new risks appear or circumstances change.

Now you're aware of what pregnancy risk assessments are, it's time to conduct one. Follow the steps as closely as you can to ensure you comply with Health & Safety laws. These include:

• Prepare accordingly: The first step in any Health & Safety risk assessment is to prepare accordingly. This includes asking a competent person to help you perform one, understanding what factors you need to consider, and how you plan to measure risks. You should also take into account the medical recommendations provided by a doctor or midwife.
• Assess the safety risks: Now you've prepared, you must assess the safety risks your workplace poses. To do so, you should review your existing general risk management and how effective it is. Conduct a site walkaround and consider what hazards could specifically affect pregnant workers and new mothers. Take into account the likelihood of the hazard causing harm.
• Record your findings: Once you've assessed the risks, you should record your findings. This will maintain your legal compliance - in the rare case it's questioned down the line. And will also help you should you ever need to refer back to measures you have made.
• Implement necessary control measures: Finally, it's time to remove or reduce the Health & Safety risks. You can do this by implementing control measures and significant changes to your workplace, or offering suitable alternative work. Discuss these controls with your competent person - they should have the knowledge to advise what would work best.

Once you've completed the assessment, inform your worker of the risks you have identified, as well as the safety measures you have implemented. You might need to discuss suitable alternative work, or suspension on full pay if the health and safety risks cannot be sufficiently reduced.

It's your legal duty to care for your employees - so take the time to understand their needs, and what works best for them. Ultimately, it will help you create a more inclusive workplace where everyone feels safe enough to excel.

You must ensure you perform a pregnancy risk assessment for any pregnant workers in your business. This includes monitoring employees as their pregnancy progresses, removing safety issues at work, and complying with the law.

Failure to do so could mean you don't properly care for an employee's safety. Consequently, they might submit a claim to an employment tribunal, which could lead to financial loss and reputational damage.

Peninsula offers expert advice on pregnancy risk assessments. Our teams provide 24/7 Health & Safety advice which is available 365 days a year. We take care of everything when you work with our Health & Safety experts.

Want to find out more? Contact us on 0800 028 2420 and book a free consultation with a Health & Safety consultant today.

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What are risk assessments?

A risk assessment is an examination of anything in your work that can cause harm to people.

Why are risk assessments important?

Risk assessments are vitally important to ensure the safety of employees and non-employees, such as customers. A risk assessment can help employers to understand what control measures are required throughout their site.

How do you carry out a risk assessment?

There are five stages to carrying out a risk assessment, they are: identify potential hazards, assess who may be harmed, evaluate the risks, record significant findings, and review your risk assessment.

How can Peninsula help with risk assessments?

Peninsula's risk assessment services will provide you with all the advice you need on carrying out risk assessments, ensuring you complete is thoroughly and keep your employees and customers safe.

Can you be taken to an employment tribunal over risk assessments?

Yes if you fail to carry out a risk assessment and an employee is injured, you can be taken to a tribunal. If found guilty, you can be hit with both financial and reputational damages.

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Maternity Risk Assessment

As an employer, it is important that you understand the law regarding risk assessments for pregnant workers and new mothers. You must, by law, complete a general workplace risk assessment to cover your workers’ specific needs. Employers also need to conduct an individual risk assessment if an employee has informed you that they are either...

Read Time: 9 Minutes

As an employer, it is important that you understand the law regarding risk assessments for pregnant workers and new mothers. You must, by law, complete a general workplace risk assessment to cover your workers’ specific needs.

Employers also need to conduct an individual risk assessment if an employee has informed you that they are either pregnant, breastfeeding or have given birth in the previous 6 months.

As part of continual assessments, you will need to review your general risk management and controls for employees who are new mothers.

Maintain regular communication with them about conditions or things that may impact their work, and consult with a safety representative or trade union if they have one.

If you need instant, actionable advice on maternity and other HR issues, contact Employer Advice on 0800 470 0613 .

What is a Maternity Risk Assessment?

Maternity risk assessments are generally the same as normal risk assessments. The only difference is that this type of risk assessment will take a deeper look at the hazards and safety risks that present themselves to pregnant women.

It is important to review your current risk assessments because there is a likelihood that it doesn’t cover any or all of the specific risks to pregnant employees. Failure to conduct a proper risk assessment could expose your business to litigation .

We would highly recommend that you use our free template to create a new risk assessment specifically for maternity.

The purpose of conducting this assessment is to identify risks to expectant mothers and new mothers. Following the assessment, you should outline the measures that you are putting in place to reduce or avoid the risks where possible.

Conducting a health and safety risk assessment

If you have pregnant workers you need to carry out a health and safety risk assessment.

It’s recommended to carry out an individual risk assessment, as each of your employees will need a different work condition and be at different stages of their pregnancy.

While your health and safety executive is carrying out the risk assessment you should make sure you keep your pregnant workers in the loop and get their feedback.

Your duty of care and responsibility doesn’t stop at the end of the risk assessment. You need to remain vigilant and remove any risks that are identified.

When should you complete a maternity risk assessment?

You should carry out individual risk assessments when your employee comes and tells you in writing that they are pregnant (normally no later than 15 weeks before the baby is due), have given birth in the last 6 months or is breastfeeding.

After completing the risk assessment you may conclude the work environment is deemed too dangerous for a pregnant worker or will pose safety risks as the pregnancy progresses.

Under the Employment Rights Act 1996, employees should be offered suitable alternative work where possible. This new work has to be appropriate for pregnant workers and new mothers, on the same terms they were previously on and with the same pay.

If it isn’t possible to find suitable alternative work, the pregnant employee should be suspended with full pay, to help protect them and their unborn child. This needs to remain in line with regulations 16 to 18 of the Management of Health and Safety at Work Regulations 1999 .

Why should you conduct an individual risk assessment?

As an employer, you want to make sure that all your employees are safe when they are carrying out their roles. This doesn’t change when an employee becomes pregnant.

• Legally, you have a duty of care to the pregnant employee and their unborn child.
• You must be able to identify health and safety risks that need to be improved to keep your employees safe.
• Being vigilant will help you avoid grievances and litigation claims.
• Help boost employee retention.
• It will help protect your company from reputational damage.

What to include in an individual risk assessment

When you are carrying out a risk assessment for pregnant workers, think about the common safety risk and hazards that someone might come across. You can use your existing general risk assessment as a starting point.

We’ve put together some common risks, but this isn’t a complete list.

Common Risks

Posture and position.

Pregnant workers and new mothers are potentially more likely to suffer injuries.

A pregnant worker’s posture can cause problems, particularly as their pregnancy progresses when an employee returns and their working conditions.

As part of your risk assessment, you should ensure that pregnant workers aren’t

• Carrying or heavy lifting loads.
• Sitting or standing for long periods of time.
• Using workstations that aren’t suitable, workstations that are causing posture issues.

Working Conditions

Working conditions can have a severe impact on new and expectant mothers’ health.

It’s important to remember that not all of your employees are going to be affected in the same way.

Mental and physical risks are likely to be higher during pregnancy and the time after birth.

• To avoid health and safety risks you should assess work areas where pregnant employees or new mothers are situated. Assess for:
• For long hours.
• Temperature. 
• Long working hours.

Risk of Physical Injury

In certain jobs, there is a risk of physical injury. For pregnant workers and new mothers, these risks can have serious consequences.

You may be required to provide extra control measures to help protect pregnant workers and new mothers.

• Working from height.
• Work-related violence.
• Vibration exposure.
• Working alone.

Exposure to Harmful Substances

Some roles require workers to handle harmful and toxic chemicals, such as radioactive materials, and other toxic chemicals.

This raises health and safety concerns, particularly when pregnant workers and new mothers are handling them, there is a risk that the harmful agents will be passed on to the child.

Harmful chemicals could include;

• Radioactive materials.
• Toxic chemicals.
• Infectious diseases.
• Antimitotic drugs.

Personal Protective Equipment (PPE)

Personal protective equipment isn’t typically designed for pregnant workers and new mothers.

It’s important to ensure that their PPE is comfortable and safe for them to use regularly, particularly as their pregnancy progresses.

With this in mind, think about what measures you put in place if their PPE isn’t suitable anymore, for example, changing their work activity or environment.

How Employer Advice can help you.

If you have an employee who is pregnant, breastfeeding or has given birth in the past six months, why not check out our free, comprehensive maternity risk assessment download.

Employer Advice has a team of dedicated HR and employment law experts who only work with employers. With over 80 years of experience in helping employers take the stress of handling their HR and employment law obligations. Get in touch with one of the Employer Advice experts on 0800 470 0613 .

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Pregnancy and COVID-19: What are the risks?

You may wonder how coronavirus disease 2019 (COVID-19) could affect your risk of illness, birth plan or time bonding with your baby. You also might have questions about the safety of the COVID-19 vaccines. Here's what you need to know.

COVID-19 risks during pregnancy

Pregnant people seem to catch the virus that causes COVID-19 at about the same rate as people who aren't pregnant. Also, pregnant people usually get better without needing care in the hospital. But pregnancy is a factor that raises the risk of severe COVID-19. That risk stays higher for at least a month after giving birth.

And the risk continues to go up if a pregnant person has other health issues linked to severe COVID-19. Examples of these health issues are obesity, diabetes, high blood pressure or lung disease.

Being very sick with COVID-19 means that a person's lungs don't work as well as they should. Severe or critical COVID-19 is treated in the hospital with oxygen and other medical help to treat damage throughout the body. Severe COVID-19 can lead to death.

Pregnant people with severe COVID-19 also may be more likely to develop other health problems as a result of COVID-19. They include heart damage, blood clots and kidney damage. Moderate to severe symptoms from COVID-19 have also been linked to higher rates of preterm birth, high blood pressure or preeclampsia.

These risks may shift as the virus that causes COVID-19 changes. Risks also may change as disease prevention and treatment evolve. But risks are lowered significantly when a pregnant person gets the COVID-19 vaccine.

Preventing COVID-19 during pregnancy and breastfeeding

The Centers for Disease Control and Prevention recommends getting a 2023-2024 COVID-19 vaccine if:

• You are planning or trying to get pregnant.
• You are pregnant now.
• You are breastfeeding.

Staying up to date on your COVID-19 vaccine helps prevent severe COVID-19 illness. It also may help a newborn avoid getting COVID-19 if you are vaccinated during pregnancy.

People at higher risk of serious illness can talk to a healthcare professional about additional COVID-19 vaccines or other precautions. It also can help to ask about what to do if you get sick so you can quickly start treatment.

While you’re pregnant, it’s important for you and those in your household to:

• Test for COVID-19. If you have COVID-19 symptoms, test for the infection. If you are exposed, test five days after you came in contact with the virus. In the United States, the Food and Drug Administration, also known as the FDA, approves or authorizes the tests. On the FDA website, you can find a list of the tests that are validated and their expiration dates. You also can check with your healthcare professional before buying a test if you have any concerns.
• Keep some distance. Avoid close contact with anyone who is sick or has symptoms, if possible.
• Wash your hands. Wash your hands well and often with soap and water for at least 20 seconds. Or use an alcohol-based hand sanitizer with at least 60% alcohol.
• Cover your coughs and sneezes. Cough or sneeze into a tissue or your elbow. Then wash your hands.
• Clean and disinfect high-touch surfaces. For example, clean doorknobs, light switches, electronics and counters regularly.

Try to spread out in crowded public areas, especially in places with poor airflow. This is important if you have a higher risk of serious illness.

The CDC recommends that people wear a mask in indoor public spaces if you're in an area with a high number of people with COVID-19 in the hospital. They suggest wearing the most protective mask possible that you'll wear regularly, that fits well and is comfortable.

COVID-19 and prenatal care

Unlike earlier in the pandemic, in-person prenatal visits typically are not disrupted by COVID-19.

If you test positive for COVID-19, your healthcare professional will want to discuss your options with you. That might mean a virtual or in-person appointment to figure out how to best keep track of your health. It may help to know that in most cases, the COVID-19 infection doesn't spread to the unborn baby.

If you test positive for COVID-19 and have symptoms, your healthcare team will monitor you closely. A healthcare professional may ask about your symptoms, review your other medical conditions and determine your risk of serious illness. You may be offered medicine to block the infection from getting worse. Treatment with these medicines may be a pill that you swallow, or a liquid given through a needle into a vein.

You also may be asked to use a device to monitor your oxygen level, called a pulse oximeter.

After the infection, your healthcare professional may plan on extra imaging tests to make sure the unborn baby is growing as expected.

COVID-19 and giving birth

If you test positive for COVID-19 close to when you give birth, you may not need to change your birth plan.

But it's also possible that your healthcare professional will suggest a change in timing or delivery options for your safety. People who also are managing high blood pressure linked to pregnancy or preeclampsia are more likely to be monitored in the hospital if they get COVID-19.

After the baby is born, research suggests it's safe for your baby to stay with you even if you have COVID-19. If you are too ill to care for your baby, your healthcare professional may suggest the baby stay in another hospital area.

To limit your baby's exposure to the virus, wear a well-fitting face mask and have clean hands when caring for your newborn. Stay a reasonable distance from your baby when not feeding, if possible.

Breastfeeding and COVID-19

If you have COVID-19 but feel well enough, there is no need to stop breastfeeding or stay separate from your baby. To avoid spreading the infection, wash your hands before breastfeeding. Also, wear a well-fitting face mask whenever you are in close contact with your baby.

If you're pumping breast milk, wash your hands before touching any pump or bottle parts and follow instructions for pump cleaning. If you need care in the hospital, you may be able to keep pumping.

COVID-19 concerns after giving birth

Staying healthy can be a big concern for new parents. Worry about COVID-19 illness for yourself or your newborn may be an added burden. But it is typical for newborns to get their first illness during their first year of life. In fact, your baby may have mild illness regularly during this first year as the baby comes in contact with the world.

If you find that worry over COVID-19 or other illness is affecting your or your baby's health, talk to your healthcare professional.

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• Berghella V, et al. COVID-19: Overview of pregnancy issues. https://www.uptodate.com/contents/search. Accessed March 18, 2024.
• COVID-19: People with certain medical conditions. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Accessed March 18, 2024.
• Goldman L, et al., eds. COVID-19: Epidemiology, clinical manifestations, diagnosis, community prevention, and prognosis. In: Goldman-Cecil Medicine. 27th ed. Elsevier; 2024. https://www.clinicalkey.com. Accessed March 20, 2024.
• Smith, ER. Clinical risk factors of adverse outcomes among women with COVID-19 in the pregnancy and postpartum period: A sequential, prospective meta-analysis. American Journal of Obstetrics and Gynecology. 2023; doi:10.1016/j.ajog.2022.08.038.
• COVID-19 vaccines while pregnant or breastfeeding. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html. Accessed March 18, 2024.
• Barros, FC. Maternal vaccination against COVID-19 and neonatal outcomes during omicron: INTERCOVID-2022 study. American Journal of Obstetrics and Gynecology. 2024; doi: 10.1016/j.ajog.2024.02.008.
• Interim clinical considerations for use of COVID-19 vaccines in the United States. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html. Accessed March 20, 2024.
• How to protect yourself and others. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed March 20, 2024.
• COVID-19 overview and infection prevention and control priorities in non-U.S. healthcare settings. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/overview/index.html. Accessed March 20, 2024.
• Use and care of masks. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/about-face-coverings.html. Accessed March 20, 2024.
• Hughes BL, et al. COVID-19: Antepartum care of pregnant patients with symptomatic infection. https://www.uptodate.com/contents/search. Accessed March 18, 2024.
• AskMayoExpert. COVID-19: Pregnancy. Mayo Clinic; 2024.
• CDER scientific review documents supporting emergency use authorizations for drug and biological therapeutic products, COVID-19. U.S. Food and Drug Administration. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological. Accessed March 18, 2024.
• AskMayoExpert. COVID-19: Drug regimens and other treatment options. Mayo Clinic; 2023.
• COVID-19 testing: What you need to know. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html. Accessed March 18, 2024.
• At-home OTC COVID-19 diagnostic tests. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests. Accessed March 20, 2024.
• COVID-19, Pregnancy, childbirth, and breastfeeding: Answers from Ob-Gyns. The American College of Obstetricians and Gynecologists. https://www.acog.org/womens-health/faqs/coronavirus-covid-19-pregnancy-and-breastfeeding. Accessed March 19, 2024.
• Cook WJ, et al., eds. Mayo Clinic Guide to Your Baby's First Years: Newborn to Age 3. Mayo Clinic Press; 2020.
• COVID data tracker. Centers for Disease Control and Prevention. https://covid.cdc.gov/covid-data-tracker/#datatracker-home. Accessed March 26, 2024.

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A risk-benefit assessment of pharmacological and nonpharmacological treatments for nausea and vomiting of pregnancy

Affiliation.

• 1 Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada.
• PMID: 10804035
• DOI: 10.2165/00003495-200059040-00005

Despite evidence of fetal safety, most antiemetics are contraindicated in pregnancy. We summarise a risk-benefit analysis of the literature on safety and effectiveness of pharmacotherapy and nontraditional therapy for nausea and vomiting of pregnancy (NVP) to provide evidence-based guidelines on the management of NVP. The medical literature was scanned for controlled studies on the human teratogenicity and effect of various antiemetics in pregnant women. Data were pooled based on drug/therapy class and summarised to determine relative risk with 95% confidence interval (for malformations and failure rates for NVP) and homogeneity (chi-square test). Evidence from controlled trials has demonstrated the safety and efficacy of the following drugs for the treatment of varying degrees of NVP: doxylamine/pyridoxine+/-dicycloverine (dicyclomine), antihistamine H1 receptor antagonists, and phenothiazines (as a group). However, pooled data for doxylamine/pyridoxine+/-dicycloverine, H1 antagonists and phenothiazines were not homogeneous. Other therapies, such as pyridoxine alone, metoclopramide, ondansetron and the corticosteroids may be beneficial in managing NVP. However, limited efficacy studies and the paucity of well-controlled safety studies may limit the use of some of these agents among patients not responsive to first-line agents. Well-controlled safety and effectiveness trials in patients with NVP are lacking for nonpharmacological treatments (e.g. acupressure). NVP can be managed safely and effectively. Further trials must be conducted in order to determine the true effectiveness of certain agents in patients with NVP.

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• Safety considerations surrounding use of treatment options for nausea and vomiting in pregnancy. Koren G. Koren G. Expert Opin Drug Saf. 2017 Nov;16(11):1227-1234. doi: 10.1080/14740338.2017.1361403. Epub 2017 Aug 9. Expert Opin Drug Saf. 2017. PMID: 28749713 Review.
• Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment. O'Donnell A, McParlin C, Robson SC, Beyer F, Moloney E, Bryant A, Bradley J, Muirhead C, Nelson-Piercy C, Newbury-Birch D, Norman J, Simpson E, Swallow B, Yates L, Vale L. O'Donnell A, et al. Health Technol Assess. 2016 Oct;20(74):1-268. doi: 10.3310/hta20740. Health Technol Assess. 2016. PMID: 27731292 Free PMC article. Review.
• The pharmacologic management of nausea and vomiting of pregnancy. Niebyl JR, Briggs GG. Niebyl JR, et al. J Fam Pract. 2014 Feb;63(2 Suppl):S31-7. J Fam Pract. 2014. PMID: 24527483 Review.
• Evidence-based view of safety and effectiveness of pharmacologic therapy for nausea and vomiting of pregnancy (NVP). Magee LA, Mazzotta P, Koren G. Magee LA, et al. Am J Obstet Gynecol. 2002 May;186(5 Suppl Understanding):S256-61. doi: 10.1067/mob.2002.122596. Am J Obstet Gynecol. 2002. PMID: 12011897 Review.
• Attitudes, management and consequences of nausea and vomiting of pregnancy in the United States and Canada. Mazzotta P, Maltepe C, Navioz Y, Magee LA, Koren G. Mazzotta P, et al. Int J Gynaecol Obstet. 2000 Sep;70(3):359-65. doi: 10.1016/s0020-7292(00)00255-1. Int J Gynaecol Obstet. 2000. PMID: 10967171
• Anti-emetic effects of thalidomide: Evidence, mechanism of action, and future directions. Andrews PLR, Williams RSB, Sanger GJ. Andrews PLR, et al. Curr Res Pharmacol Drug Discov. 2022 Oct 27;3:100138. doi: 10.1016/j.crphar.2022.100138. eCollection 2022. Curr Res Pharmacol Drug Discov. 2022. PMID: 36568268 Free PMC article. Review.
• Nausea and vomiting of pregnancy - What's new? Bustos M, Venkataramanan R, Caritis S. Bustos M, et al. Auton Neurosci. 2017 Jan;202:62-72. doi: 10.1016/j.autneu.2016.05.002. Epub 2016 May 13. Auton Neurosci. 2017. PMID: 27209471 Free PMC article. Review.
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• A Systematic Review and Meta-Analysis of the Utility of Corticosteroids in the Treatment of Hyperemesis Gravidarum. Grooten IJ, Vinke ME, Roseboom TJ, Painter RC. Grooten IJ, et al. Nutr Metab Insights. 2016 Feb 4;8(Suppl 1):23-32. doi: 10.4137/NMI.S29532. eCollection 2015. Nutr Metab Insights. 2016. PMID: 26877629 Free PMC article. Review.
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• Drug Safety Update

Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

General advice for healthcare professionals:

• in pregnancy for prophylaxis of migraine
• in pregnancy for epilepsy unless there is no other suitable treatment
• are using highly effective contraception
• have a pregnancy test to exclude pregnancy before starting topiramate
• are aware of the risks from use of topiramate
• please see specific advice for prescribers and advice for dispensers
• ensure women of childbearing potential sign the Risk Awareness Form, you will receive materials including the Risk Awareness Form by post in the coming weeks to use in the implementation of the Pregnancy Prevention Programme
• report suspected adverse drug reactions associated with topiramate to the Yellow Card scheme

Advice for healthcare professionals to provide to patients:

• new measures are being introduced because there is evidence that taking topiramate during pregnancy can increase the risk to the baby of congenital malformation, low birth weight, intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder
• use effective birth control (contraception) at all times during your treatment with topiramate and for at least 4 weeks after the last dose
• topiramate may interact with some hormonal contraceptives. Your General Practitioner (GP), specialist, sexual health and contraception clinic or contraception service in community pharmacy will discuss which method of birth control is best for you
• if you are thinking about having a baby, make an appointment with your GP. Do not stop using topiramate and contraception before you have talked to your doctor
• if you think you are pregnant and are taking topiramate for epilepsy, do not stop using topiramate. This may cause your seizures to start again or happen more often and last longer. Make an urgent appointment with your GP or epilepsy team (within a few days)
• if you think you are pregnant and are taking topiramate for migraine prevention, stop taking topiramate straight away and contact your GP
• it is important to visit your doctor to review your treatment at least once each year
• always read the safety leaflet that comes with your medicine and consult the new Patient Guide for information about the risk of topiramate use during pregnancy

Review of harms of topiramate use during pregnancy

Topiramate is indicated for the prophylaxis of migraine and for the treatment of epilepsy. It is available as tablets, a liquid oral solution and as capsules that can be swallowed whole or sprinkled on soft food. The brand name of topiramate is Topamax, and so this may also appear on the box. Topiramate has been contraindicated in pregnancy for the prophylaxis of migraine since 2010.

Following a comprehensive review of the safety of antiseizure medications in pregnancy, including topiramate, new safety advice was published in January 2021. Since then, new study data has become available reporting a potential increased risk of autism spectrum disorder and effects on learning development in children exposed to topiramate during pregnancy [footnote 1] . These new data, and data suggesting increasing use of topiramate in women of childbearing age, triggered a new safety review . This review examined the available data on the risk of congenital malformations, effects on growth and development of the baby, and the risk of neurodevelopmental disorders when topiramate is used during pregnancy.

The review concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child (both from the confirmed risks of congenital malformations and low birth weight and the potential risk of neurodevelopmental disorders). The accumulating data suggest that:

• topiramate is amongst the antiseizure medications associated with a higher risk of congenital malformations (approximately 4 to 9 per 100 babies compared to around 1 to 3 babies in every 100 in the general population) [footnote 2]
• the risk of congenital malformations with topiramate appears to be dose-dependent, however, a threshold dose below which no risk exists cannot be established
• topiramate is associated with a high prevalence of babies being born small for gestational age and weighing less at birth (approximately 18 per 100 babies affected); this is higher than the risk in babies born to women with epilepsy not taking antiseizure medication (approximately 5 in 100 babies affected) and may be higher than the risk with some other antiseizure medications [footnote 3]
• topiramate may be associated with an approximately 2 to 3 times increased risk of intellectual disability, autistic spectrum disorders and attention deficit hyperactivity disorder compared with children born to mothers with epilepsy not taking antiseizure medication. [footnote 1] [footnote 4] [footnote 5] [footnote 6] [footnote 7] [footnote 8]

Full information on the studies considered and their findings, can be found in the Public Assessment Report . This report also includes a plain language summary of the review and findings.

New safety measures

Due to the accumulating data on these harms, further restrictions are being introduced with regards to the use of topiramate in women of childbearing potential and in pregnancy.

The use of topiramate is now contraindicated:

• in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled (for all indications)

Materials to support the Pregnancy Prevention Programme:

Healthcare professionals will receive materials by post in the coming weeks to support discussions with patients and implementation of the Pregnancy Prevention Programme. These materials are also available online and consist of :

Patient Guide for Migraine and Epilepsy - to be provided to all girls and women of childbearing potential who are started on, or continue to use, topiramate-containing medicines

Guide for Healthcare Professionals for Migraine and Epilepsy

Risk Awareness Form for Migraine and Epilepsy - for the healthcare professional and the patient (or responsible person) to sign at initiation of treatment with topiramate and at annual treatment reviews. The patient should receive a copy of this form, a copy should be filed in the patient’s medical notes, and, if necessary, a copy sent to the patient’s GP

Patient Card - to be given by pharmacists to all female patients who are dispensed topiramate to inform them of the risks

Advice for prescribers:

• all women of childbearing potential being treated with topiramate- containing medicines must follow the requirements of the Pregnancy Prevention Programme. These conditions are also applicable to female patients who are not sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy
• assess their potential for pregnancy and discuss the need for them to be on the Pregnancy Prevention Programme
• ensure that pregnancy has been excluded, by means of a negative pregnancy test, prior to starting treatment with topiramate
• inform them of the potential risks of topiramate use in pregnancy and counsel them on treatment options
• discuss with them the need to use highly effective contraception throughout treatment and for at least four weeks after the last dose of topiramate. See guidance from Faculty of Family Planning and Sexual Health on potential drug interactions with hormonal contraceptives and what this means for topiramate
• complete the Risk Awareness Form with the patient (or responsible person)
• provide a copy of the Patient Guide to the patient (or responsible person)
• identify all women and girls of childbearing potential on topiramate and invite them in for review
• complete the Risk Awareness Form with the patient (or responsible person) and at each annual review

Advice for dispensers:

• a visual warning symbol will be added to the pack of topiramate. This symbol will show a pregnant woman in a red circle with a line through it, with warning text about the risks and information about the new measures
• until warning symbols are present on packs, stickers will be available to print locally on eMC
• pharmacists should dispense in whole packs whenever possible. This will ensure that patients always see the warning symbol and receive the statutory information
• pharmacists should give the patient card to female patients when dispensing topiramate
• ask women or girls of childbearing potential if they are taking highly effective contraception, if they are not, pharmacists should advise them to contact their GP for a follow-up appointment

Report suspected reactions on a Yellow Card

Please continue to report suspected adverse drug reactions to the  Yellow Card scheme . Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:

• the  Yellow Card website
• the Yellow Card app; download from the  Apple App Store  or  Google Play Store
• some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)

When reporting please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.

Article citation: Drug Safety Update volume 17, issue 11: June 2024: 1

Bjørk MH and others. Association of Prenatal Exposure to Antiseizure Medication with Risk of Autism and Intellectual Disability . JAMA Neurology 2022: volume 79, pages 672 to 681.  ↩   ↩ 2

Cohen JM and others. Comparative Safety of Antiseizure Medication Monotherapy for Major Malformations . Annals of Neurology 2023: volume 93, pages 551 to 562.  ↩

Hernandez-Diaz S and others. Fetal growth and premature delivery in pregnant women on anti-epileptic drugs . Annals of Neurology 2017: volume 82, pages 457to 465.  ↩

Blotière PO and others. Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy: a French nationwide population-based cohort study . BMJ Open 2020: volume 10, page e034829.  ↩

Bromley RL and others. Cognition in school-age children exposed to levetiracetam, topiramate, or sodium valproate . Neurology 2016: volume 87, pages 1943 to 1953.  ↩

Dreier JW and others. Prenatal Exposure to Antiseizure Medication and Incidence of Childhood- and Adolescence-Onset Psychiatric Disorders . JAMA Neurology 2023: volume 80, pages 568 to 577.  ↩

Hernandez-Diaz S and others. Topiramate during pregnancy and the risk of neurodevelopmental disorders in children. Pharmacoepidemiology and Drug Safety 2022: volume 31, page 11. [Full study unavailable at time of review]  ↩

Knight R and others. Adaptive behaviour in children exposed to topiramate in the womb . A thesis submitted to the University of Manchester for the degree of Doctor of Clinical Psychology in the Faculty of Biology, Medicine, and Health. 2020.  ↩

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Orlando Cepeda dies

Preeclampsia can be fatal for pregnant people and babies. New blood tests aim to show who’s at risk

This Nov. 2005 file photo shows future parents awaiting the arrival of their first child in Carlsbad, Calif. When you’re expecting a baby, you hope nothing goes wrong. But at least one in 20 pregnant patients develops a scary complication called preeclampsia, a high blood pressure disorder that kills 70,000 women and 500,000 babies worldwide every year. New blood tests promise to help doctors predict and manage the condition. (AP Photo/Julie Busch, file)

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When you’re expecting a baby, you hope nothing goes wrong. But at least one in 20 people who are pregnant develop a scary complication called preeclampsia, a high blood pressure disorder that kills 70,000 women and 500,000 babies worldwide every year.

There was no way to know when it might strike — until now. New blood tests may help doctors predict and manage this dangerous condition.

“When something bad happens in pregnancy, you want to catch it early so you can avoid adverse outcomes for the mom and the baby,” said Dr. S. Ananth Karumanchi with Cedars-Sinai in Los Angeles.

What is preeclampsia?

The condition affects both the mother and baby and can occur in the second half of pregnancy or the postpartum period. The exact causes aren’t known.

Besides high blood pressure, other signs of preeclampsia include protein in the urine, severe headaches, changes in vision, nausea and sudden swelling in your face and hands. It’s generally diagnosed by checking for protein in the urine, measuring blood pressure and following up with other tests if warranted.

Once you have preeclampsia, it can progress rapidly and cause organ damage, stroke, preterm birth, slow growth in the baby and other problems.

To prevent the condition, the American College of Obstetricians and Gynecologists recommends pregnant patients get low-dose aspirin if they have one or more particular risk factors , such as chronic high blood pressure, Type 1 or 2 diabetes before pregnancy or kidney disease.

This article is part of AP’s Be Well coverage, focusing on wellness, fitness, diet and mental health. Read more Be Well.

The primary treatment for preeclampsia is to deliver the baby or manage the condition until the baby can be delivered. People with severe preeclampsia are usually hospitalized and may be given medicines to lower blood pressure, prevent seizures and help the fetus’ lungs develop.

How do the new tests work?

The tests measure “biomarkers” for preeclampsia in the blood, objective measures that show what’s happening in an organism at any given moment.

At this point, there are only a few tests on the market.

One, by Labcorp, is designed to be performed between 11 and 14 weeks gestation on any pregnant patient. It measures four early pregnancy biomarkers that, combined with other factors, help determine the risk of developing preeclampsia before 34 weeks of pregnancy.

Two other tests — another by Labcorp and one from Thermo Fisher Scientific — are used in the second and third trimesters on hospitalized patients to assess whether they are at risk of progressing to severe preeclampsia within a couple of weeks. More tests by other companies are in the pipeline .

“They absolutely represent an exciting advancement, especially when you look at the field of preeclampsia and the fact that there’s been very little new introduced to the field in decades,” said Eleni Tsigas, CEO of the nonprofit Preeclampsia Foundation. She lost one baby and also nearly died because of undiagnosed preeclampsia about two decades ago, and developed it again in her second pregnancy and gave birth to a son who spent time in neonatal intensive care.

The new blood tests augment but don’t replace a doctor’s judgment, she added, “basically giving them insight that they haven’t had before. And that’s particularly useful in cases where things are in the gray zone,” such as when you have preexisting health problems such as chronic high blood pressure or obesity.

Should you ask for a test?

“If I were pregnant today then I absolutely would,” Tsigas said.

Though “there’s no therapy right at the moment,” Karumanchi said, doctors can closely watch those at higher risk and do more follow-ups with them. For patients shown to be at low risk, the tests offer reassurance.

The tests could also help speed up the development of new treatments, he said, because researchers can identify patients at risk who might be willing to join studies.

Still, some OB-GYNs may not offer the tests immediately because they are so new, Tsigas said. But she figures: Why wait?

“You just have to look at the mortality and morbidity rates related to preeclampsia to know that clearly we have work to do,” she said. “So I don’t think there’s a downside to adding tools to a nearly empty toolbox.”

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.