Protection by Exclusion: Another Missed Opportunity to Include Pregnant Women in Research During the Coronavirus Disease 2019 (COVID-19) Pandemic.

Abstract

Coronavirus disease 2019 (COVID-19) is a novel infectious disease that started in Wuhan, China, and has rapidly spread all across the world. With limited ability to contain the virus and relatively high transmissibility and case fatality rates, governmental institutions and pharmaceutical companies are racing to find therapeutics and vaccines that target this novel coronavirus. However, once again, pregnant and breastfeeding women are excluded from participating in clinical trials during this pandemic. This "protection by exclusion" of pregnant women from drug development and clinical therapeutic trials, even during epidemics and pandemics, is not unprecedented. Moreover, it is both misguided and not justifiable and may have excluded them from potentially beneficial interventions. This is another missed opportunity to obtain pregnancy-specific safety and efficacy data, because therapeutics developed for men and nonpregnant women may not be generalizable to pregnant women. Therefore, we recommend and urge the scientific community and professional societies that, without clear justification for exclusion, pregnant women should be given the opportunity to be included in clinical trials for COVID-19 based on the concepts of justice, equity, autonomy, and informed consent.