A recent research study has revealed that pregnant women are often left out of clinical drug trials that assess safety, which raises important concerns about the effectiveness of these medications for both maternal and child health.
A recent study conducted by researchers at the Brown University School of Public Health has found that pregnant women are frequently excluded from clinical drug trials designed to test safety, leading to serious concerns regarding the effectiveness of these medications for maternal and child health.
Published in the American Journal of Obstetrics and Gynecology, the research analyzed 90,860 drug trials involving women aged 18 to 45 over the past 15 years and discovered that only 0.8% included pregnant women as participants. Approximately 75% of the studies excluded this group entirely, which may leave significant safety and efficacy questions unaddressed.
“Excluding pregnant women from drug trials makes it difficult to determine whether the medication is safe for mothers and their children,” explained Alyssa Bilinski, an assistant professor of health services, policy, and practice, as well as biostatistics at Brown’s School of Public Health. “This means that some individuals might opt to take medications even without solid evidence, potentially resulting in harmful side effects. Conversely, others may avoid beneficial medications due to the lack of sufficient safety data.”
About 24% of the studies reviewed did not clarify whether pregnant participants were involved. However, further analysis indicated that they were generally not included. Trials that did include pregnant participants primarily targeted pregnancy-related issues, labor, and the prevention of early labor, while chronic health conditions impacting pregnant women and their children—like diabetes and asthma—were largely ignored.
“We identified only 19 trials for chronic non-infectious conditions such as anxiety, depression, and asthma that involved pregnant participants,” Bilinski noted. “Although it may seem risky to involve pregnant individuals in research, it is even more concerning to leave them in the dark due to insufficient information.”
Notably, the inclusion rates of pregnant participants in drug trials have remained unchanged for the past 15 years, despite calls for increased involvement, as indicated by the researchers’ findings.
Randomized control trials adhere to a systematic approach for assessing medication safety and efficacy. They involve giving treatment to a randomly chosen group of participants while denying treatment to another group. These trials reliably demonstrate a drug’s effectiveness and potential side effects.
Bilinski pointed out that it wasn’t until 1962 that the U.S. Food and Drug Administration required drug manufacturers to prove the safety and efficacy of their products, and it was only in 1993 that trials were mandated to include women.
“That wasn’t that long ago,” Bilinski remarked. “We hope that in 30 years, the lack of reliable evidence regarding medication safety during pregnancy will appear as outdated and strange as the exclusion of women from trials does to us today.”
Alongside Bilinski, the research was contributed to by Natalia Emanuel, a research economist at the Federal Reserve Bank of New York, utilizing data from ClinicalTrials.gov.
