Pregnant women aren’t included in most COVID-19 treatment trials. They should be.
As healthcare teams around the world hone in on the best treatments and therapies for COVID-19 patients, one group is largely excluded from the conversation and studies: pregnant women.
That’s according to a group of World Health Organization (WHO) researchers who examined hordes of clinical studies and determined that excluding pregnant women from clinical trials actually leaves this group with fewer opportunities for safe and effective treatments.
Though scientists aren’t quite sure why, there is some evidence that pregnant women with COVID-19 might be at an increased risk of severe outcomes and require more care, including intensive care and mechanical ventilation, compared to non-pregnant women. Further, COVID-19 might increase the risk for adverse pregnancy outcomes, like preterm birth, according to the Centers for Disease Control and Prevention.
Ironically, pregnant women are typically excluded from trials for treatments and vaccines due to health professionals’ perceived risks and medication exposure to fetuses. Another risk may be in the act of exclusion itself.
“Without explicit and proactive efforts to recruit and retain pregnant women in therapeutic trials for COVID-19, expectant mothers will suffer from having fewer medical options available to them, because we are not including them in clinical trials,” said one of the study authors Dr. Melanie Taylor, a medical officer with WHO in Switzerland and the U.S. Centers for Disease Control and Prevention. “There is a very real possibility that treatment could become approved for treatment of COVID-19 without evidence-based guidance for use in pregnant women.”
The same is true of the COVID-19 vaccines being approved. So far, there is only limited data about the safety of COVID-19 vaccines administered during pregnancy, according to the CDC, because pregnant women were not included in the trials. But healthcare groups, including the American College of Obstetricians and Gynecologists, say pregnant women should be offered the vaccine. Moderna and Pfizer, which both have approved COVID-19 vaccines, are monitoring people in their vaccine trials who became pregnant.
Taylor and her co-authors looked at 10 COVID-19 treatment trial registries recognized by WHO, representing hundreds of studies. Pregnant women were specifically excluded from 75% to 80% of trials registered in April 2020 and July 2020, and from 75% of trials examining the use of six key drug treatments, including the drug remdesivir, which was one of the drugs used to treat President Trump after he was stricken with the virus in October 2020.
Instead of excluding pregnant women, this group should be given the choice to take part in clinical studies and make their own informed decisions about participating, the authors argued.
“Pregnant women are among the least likely to have robust, timely evidence to inform decisions around their care,” said co-author Dr. Caron Kim, medical officer from WHO and HRP in Switzerland. “[Categorizing] women as members of a vulnerable group on the basis of pregnancy status alone, rather than as individuals who are pregnant at the time of the trial, limits their individual choice, and access to potentially life-saving treatment.”
The authors published their opinion article in The Lancet. Click here to view the full article.