Details
Description
This analysis supports the U.S. Food and Drug Administration (FDA)'s participation in the European Medicines Agency (EMA)-funded project, CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)1 , to understand the natural history of COVID-19 in pregnant patients.
In this request, we evaluated the prevalence of medication use among pregnant patients with and without COVID-19 and non-pregnant patients with COVID-19 and described maternal at-risk conditions and the severity of COVID-19 in the Rapid COVID-19 Sentinel Distributed Database (SDD).
The study period includes data from January 1, 2020 to May 31, 2021. We distributed this request to six Sentinel Data Partners on September 17, 2021.
- 1CONSIGN study: COVID-19 infection and medicines in pregnancy- a multinational registry based study. European Network of Centres for Pharmacoepidemiology & Pharmacovigilance. Accessed June 1, 2022. https://catalogues.ema.europa.eu/node/3303/administrative-details