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 people. Evidence suggests that pregnant people are more likely to experience severe illness related to respiratory infections, including COVID-19, than nonpregnant people (1,2). Little information is available to support understanding the natural history of COVID-19 disease in pregnant people, or the impact of COVID-19 treatment upon pregnant people or the developing fetus.
To address vulnerable populations, including pregnant people, Sentinel 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 European Medicines Agency (EMA) has also funded a project, called “COVID-19 infectiOn aNd medicineS In pregnancy” (CONSIGN) which has drafted a protocol to study the natural history of COVID-19 disease in pregnant people. The CONSIGN study is currently being implemented in varied data sources across eight European countries.
This project will implement the following (three) aims of the CONSIGN protocol:
- To estimate the prevalence of medicines used and compare this among pregnant people with COVID‐19, pregnant people without COVID‐19, and nonpregnant people with COVID‐19.
- To describe severity and clinical outcomes of COVID‐19 disease in pregnant people with COVID‐19, according to treatments received during pregnancy, and compare these data with those of nonpregnant people of reproductive age with COVID‐19.
- To assess and compare the rates of adverse maternal and neonatal outcomes in cohorts of pregnant people with COVID-19 diagnosis in the first, second, or third trimester during pregnancy and pregnant people without 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; Jose Hernandez, 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; David Cole; Maria Kempner; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA