Historically, Black Americans have been underrepresented and often misrepresented in medical research, contributing to a deep-rooted mistrust of the healthcare system. For many Black women, that mistrust shows up as hesitation around medical recommendations, delayed care, or uncertainty about participating in clinical research.
At the same time, growing conversations around maternal health disparities have highlighted a critical gap: Black women, particularly those who are pregnant, remain significantly underrepresented in clinical trials. That lack of participation isn’t due to disinterest, but rather a complex mix of structural barriers, lived experiences, and unanswered questions about safety and trust.
Now, maternal health researchers are working to close that gap — offering clarity on what clinical trials actually involve, and whether they can be a safe option during pregnancy.
For many women, the biggest concern is safety when participating in a clinical trial.
According to the U.S. Food and Drug Administration (FDA), it may be scientifically and ethically appropriate to include pregnant women in a clinical trial. While participation can be safe, it depends on the specific study, and it’s best to speak with your provider to determine what’s right for you.
Joyce H.N. Nortey, MPH, MSBH, Sr. Director, Clinical Research & Operations at Evidation Health and Research Advisor for the Fibroid Foundation, echoes this, noting that participating in a clinical trial can be safe during pregnancy, depending on the study. She adds that pregnant women are considered a protected population in research, meaning there are additional safeguards in place. That means the studies must minimize risk, have a clear, specific purpose, and prioritize both maternal and fetal safety.
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Before any clinical trial begins, it must be reviewed by an Institutional Review Board (IRB) — an independent group that ensures the study is ethical and that participants. “That can include regular check-ins, lab testing, fetal monitoring, and tracking of any side effects,” Nortey says. And it’s important to note that excluding pregnant women from research isn’t always safer. “It can leave doctors and patients without clear data on what works and what’s safe during pregnancy,” Nortey continued.
Representation in maternal health research isn’t just about inclusion — it directly impacts care. When Black women are meaningfully included, research better reflects their experiences, yielding more accurate insights and more equitable outcomes.
Black women’s underrepresentation in clinical trials is not new — it’s rooted in both history and lived experience. Nortey explains that this mistrust stems from a long history of medical harm and lack of consent, but also from present-day experiences where many Black women feel unheard or dismissed in healthcare settings.
Several factors contribute to this, including limited access to research sites, time constraints, and a lack of communication about trial opportunities, all of which can make participation feel out of reach. In many cases, Black women are simply never informed about clinical trials at all.
This underrepresentation has real consequences. When Black women are not included in maternal health research, it can lead to gaps in data, missed warning signs, and care that doesn’t fully reflect their experiences.
When it comes to pregnancy, clinical trials are not one-size-fits-all. “It’s helpful to separate this into two categories, because they’re often confused,” Nortey shares. The first includes maternal health-specific research, which is intentionally designed for pregnant individuals. These studies often focus on conditions like gestational diabetes, blood pressure, mental health, or postpartum recovery. Many are observational or low-intervention, meaning researchers collect data rather than introduce new treatments.
The second involves pregnant individuals participating in broader clinical trials. In these cases, pregnancy is often an exclusion criterion — especially in drug trials due to unknown risks — but there are situations where participation may still be considered with additional safeguards. “So when people think about ‘clinical trials in pregnancy,’ it’s not just one thing,” Nortey explains.
While participating in a clinical trial during pregnancy can be safe, it’s ultimately important to speak with your provider about what’s best for your individual needs. If you are considering participation, Nortey emphasizes the importance of asking questions.
She recommends asking: Why is this research being done in pregnant women? What are the known and unknown risks? What will participation look like day-to-day? Will my OB-GYN be involved? Can I leave the study at any time?
Asking these questions can help you feel more informed, in control, and confident in your decision. “It’s completely normal to feel hesitant — and asking questions is one of the most important parts of making an informed decision,” Nortey says.
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