Don’t exclude pregnant women from trials
In a follow-up session, Cynthia Gyamfi-Bannerman, MD, of the University of California, San Diego, expanded on opportunities to include pregnant women in clinical research.
Clinical trials for pregnant people fall into two categories, she noted; those studying interventions to improve pregnancy outcomes and those studying interventions for common medical conditions that coexist with pregnancy. These trials are either initiated by the investigators, conducted under contract, or federally funded, Dr. Gyamfi-Bannerman said. Currently, the only obstetric clinical trials research network is the Maternal-Fetal Medicine Units Network, established in 1986 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The MFMU has conducted significant and life-saving research, but “we need more networks to focus on researching pregnancy complications,” Dr. Gyamfi-Bannerman said. Once the infrastructure exists in multiple settings, the ability to conduct trials will improve, she said.
Dr. Gyamfi-Bannerman stressed the need to engage and involve community-based physicians in clinical trials; using those relationships to enroll a more diverse population for whom working with their local physician would be more feasible than traveling to a larger clinical trial center.
She also commented on the need to include pregnant women in nonobstetric clinical trials. The exclusion of pregnant women from COVID-19 vaccine trials left clinicians with no information for guiding pregnant patients, she said. “It is important to think about why we are excluding pregnant women,” she said.
Finally, Dr. Gyamfi-Bannerman recommended a national effort to coordinate and leverage EHR data, which could have an effect on reducing maternal morbidity by facilitating the study of nonobstetric interventions in pregnancy, such as behavior interventions and mental health care.
Dr. Howell and Dr. Gyamfi-Bannerman had no financial conflicts to disclose.