Details
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. For other analyses supporting the CONSIGN protocol, please see Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis and Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis.
The goal of this analysis was to evaluate the prevalence of medication use among pregnant patients with COVID-19 compared to two 1:1 propensity-score matched comparator cohorts and to describe 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 December 31, 2022. We distributed this request to seven Sentinel Data Partners on June 30, 2023.
This analysis includes two reports:
- Report 1: This report includes pregnant patients without COVID-19 as the comparator cohort (Objective 1b of the COVID-19 pregnancy study protocol).
- Report 2: This report includes non-pregnant patients with COVID-19 as the comparator cohort (objectives 1c and 2b of the COVID-19 pregnancy study protocol).
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.
- 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