The Sentinel System can be used to address numerous questions of importance to FDA during the COVID‐19 pandemic. One population of significant interest for study is pregnant women. Evidence suggests that pregnant women are more likely to experience severe illness related to respiratory infections, including COVID‐19, than nonpregnant women (1,2). Little information is available to support understanding the natural history of COVID‐19 disease in pregnant women, or the impact of COVID‐19 treatment upon pregnant women or the developing fetus.
To address vulnerable populations, including pregnant women, Sentinel recently published a COVID‐19 Natural History Master Protocol, designed to identify multiple COVID‐19 cohorts to support a variety of on‐demand queries and subsequent descriptive and inferential studies. The protocol can be adapted to various data sources with clinically rich data and included pregnant women as a specific population of interest. The EMA (European Medicines Agency) has also funded a project, called CONSIGN (“COVID‐19 infectiOn aNd medicineS In pregnancy”) designed to understand the natural history of COVID‐19 disease in pregnant women, including disease severity and clinical outcomes of COVID-19, medications utilization, and impact of COVID-19 treatment on neonatal outcomes. The CONSIGN study will be implemented in varied data sources across eight European countries.
This project will implement the following (two) aims of the CONSIGN protocol:
- To estimate the prevalence of medicines used and compare this among pregnant women with COVID‐19, pregnant women without COVID‐19, and non‐pregnant women with COVID‐19.
- To describe severity and clinical outcomes of COVID‐19 disease in pregnant women with COVID‐19, according to treatments received during pregnancy, and compare these data with those of nonpregnant women of reproductive age with COVID‐19.
(1) Allotey J, Stallings E, Bonet M, et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. Published online September 1, 2020:m3320. doi:10.1136/bmj.m3320
(2) Ellington S. Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–June 7, 2020. MMWR Morb Mortal Wkly Rep. 2020;69. doi:10.15585/mmwr.mm6925a1
Wei Hua, MD, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Mayura Shinde, DrPH, MPH; Darren Toh, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Susan E. Andrade, ScD; Meyers Primary Care Institute, (Fallon Health, Reliant Medical Group, and University of Massachusetts Medical School), Worcester, MA
Danijela Stojanovic, PharmD, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Leyla Sahin, MD, FACOG MBA; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Ben Wong, PhD; Yueqin Zhao, PhD; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Austin Cosgrove; Jolene Damon, MPH; Patrick Dowe, MPH; Nicole R. Haug, MPH; Adee Kennedy, MS, MPH; Jenice Ko; Jennifer Lyons, PhD; Elizabeth Messenger-Jones, MSPH; Jolene Mosley; Emma Hoffman; Casie Horgan, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA