Inclusion of Pregnant Women in Clinical Research

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With the Internet at your fingertips via a smartphone or other device, it’s easier than ever to turn up results to almost any pregnancy question. Many expectant parents spend a lot of time wondering what’s safe for them and their developing baby.

The problem is that there may be little or no research on how a drug affects pregnancy. That doesn’t mean the medication is necessarily unsafe, though. Here’s why testing on pregnant people is challenging, and why your doctor might prescribe you a medication a website told you was potentially risky.

Ethical Concerns of Including Pregnant Women in Clinical Research

Although an embryo or fetus doesn’t have legal personhood status, there’s no denying the value we place on developing life in our culture. Researchers, and the review boards responsible for approving clinical trials, may be hesitant about including pregnant women in any study that has potential risk for the baby, even if it would be valuable to have data on how a particular treatment works for someone who’s pregnant.

The Institute of Medicine has recommended that pregnant women be included in clinical research, except in cases where there’s no prospect of a medical benefit, and there is a risk of significant harm to the developing fetus. Still, pregnant women tend to be severely underrepresented in research trials.

This is why you may hear that a medication you’re taking has been tested on pregnant animals, or nonpregnant women, or that information on pregnant women was collected after the fact and not through a controlled trial.

Should Pregnant Women Be Part of Clinical Trials?

If you’re pregnant, it’s perfectly natural to feel an urge to protect your baby from harm (and to be extra vigilant about looking out for potential risks). You may wonder why pregnant women should participate in studies testing new medications, if scientists don’t yet know how the drug will affect a fetus.

For one, remember that testing on pregnant women isn’t the first step in clinical trials. Researchers conduct other studies first, such as studies on pregnant animals, to assess risks as well as they can.

The fact is, your needs and health are no less important when you’re pregnant. You may have had a preexisting physical or mental health condition, such as diabetes or depression, that still needs to be managed during pregnancy. Other conditions may arise during the 9 months you’re expecting.

Meanwhile, your body changes drastically throughout pregnancy. Your blood volume nearly doubles, hormone balances shift, and your organs rearrange to accommodate a growing uterus. The dosage that worked before (or a dosage that works on a non-pregnant woman of the same weight) may not work the same way in a pregnant body’s system.

The FDA published draft guidelines for including pregnant women in clinical research. If a study meets a set of guidelines, including offering a potential direct benefit for the woman or fetus, and carrying minimal risk of harm, there could be a great potential gain in studying the effects on a pregnant population.

Why Is My Doctor Prescribing This Medicine?

You may find yourself in a situation where you doctor prescribes medication to treat a condition you have during pregnancy. When you look up the medication online, alarm bells start ringing.

“This hasn’t been tested on pregnant women!” a website may shout. “How can you put this in your body without knowing it’s safe?”

Suddenly, you feel like a bad mom before you’ve even held your baby for the first time.

If you’re concerned about a medication, ask your doctor questions! You have every right to clarify the risks and benefits, and get more detailed explanation from your doctor about why they feel you should take this drug. Some reasons you may hear are:

  • Data gathered through nonclinical research suggests that there’s minimal risk.
  • The drug is considered “Category B,” meaning there are clinical studies on animals, but not pregnant women, that have failed to demonstrate a risk to the fetus (note: FDA pregnancy categories have been discontinued since 2015. Watch a video about this here).
  • The potential benefits to your or the baby’s health outweigh potential risks.

Relying on trusted, scientifically backed sources, and understanding the research process as best as you can, can help you feel more empowered to make the best decisions you can about your medical care during pregnancy.

Jessica Sillers
Jessica Sillers is a parenting and finance writer whose work has been featured in Pregnancy & Newborn, Headspace, and more. As a new mom herself, she’s passionate about helping other parents find the community and support they need. When she’s not writing, she loves spending time with her family, reading, and hiking.

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