Recent calls to action from the medical community raise the alarm on this vital missing piece. There is very little evidence on the safety and efficacy of medications during pregnancy. Today, pregnant women take an average of five different medications. Yet, women are frequently excluded from clinical trials, particularly RCTs. This exclusion has sparked a broader movement for reform. Americans want to make pregnancy-related care safer and ensure mothers and children are healthy and thriving.
Here is a short, mostly happy tale of drug testing. Less than 70 years ago, new regulations were established requiring drug manufacturers to prove their drugs were safe and effective. The policy that banned pregnant women from clinical trials began to forgive starting in the 1980s. This change represented a radical departure from the typical way of conducting research. In 1993, federal guidelines were adopted mandating the inclusion of non-pregnant women in trials. Yet even today, it can be a frequent cause of exclusion.
According to the National Institute of Health, less than 1% of clinical drug trials with women aged 18-45 include pregnant women. More importantly, it contributes to a lack of data that could help inform safer treatment alternatives. Obstetricians have long sounded the alarm about this urgent lack of research.
“Well, we don’t have as much evidence as we would like on steroid use during pregnancy,” – an obstetrician stated.
The lack of more complete data may come with tragic results, as seen in the disturbing example of thalidomide. This anti-nausea medication caused at least 8,000 babies in Europe to be born with major limb defects during the late 1950s and early 1960s. Thalidomide was never granted a license to use in the United States. Its fate was averted largely due to the watchful eye of Frances Oldham Kelsey, a principled woman at the FDA who was determined to raise serious questions about safety.
Experts argue that had an RCT been conducted in the 1950s for thalidomide, it is estimated that up to 33 children might have experienced birth defects within the trial. If we hadn’t let it out in the wild, we could have saved nearly 8,000 children. It would have prevented over 99.5% of the serious birth defects that resulted from taking it.
Those implications aren’t confined to the past. They impact today’s medical questions as well. Nausea and vomiting of pregnancy continue to be significant contributors to disability and lost workdays, but treatment options have lagged. Thus, there is an unmet need for effective therapies. With well over 90 million women in the U.S. having experienced childbirth at least once, the need for urgent action is clear.
In recent years, there have been specific instances where inclusion of pregnant individuals in clinical trials could have improved outcomes significantly. Studies estimate that pregnant participants in COVID-19 vaccine trials could have prevented up to an estimated 20% of maternal deaths due to the virus. Furthermore, it may have reduced 1% of all stillbirths between March and November 2021.
Obstetricians stress the need to weigh risks unequal treatment of conditions arising during pregnancy.
“But having difficulty breathing isn’t good for your baby either. It’s really up to you: You decide whether you feel you need the inhaler,” – another obstetrician noted.
Experts stress the importance of sharing that making decisions about any medication use while pregnant is a complicated process. It takes a solid bedrock of clinical evidence to truly inform decision making in treatment modalities.
This rising recognition of these underlying factors has fueled a swell of support, particularly from patients and patient advocates, to change such clinical trial policies. Medical professionals and researchers are rallying for changes that would allow pregnant women to participate in RCTs, thereby enriching the evidence base concerning medications used during pregnancy.
