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 Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis.
In this request, we completed the following objectives: A) estimated the prevalence of adverse maternal outcomes by trimester of COVID-19 infection and by COVID-19 severity among pregnant patients with COVID-19; B) compared rates of adverse maternal outcomes among pregnant patients with COVID-19 to those without COVID-19 using a 1:1 propensity score (PS)-matched analysis; and C) evaluated the impact of medications used to treat COVID-19 on adverse maternal outcomes by assessing incidence of adverse maternal outcomes among pregnant patients with COVID-19 that had medication use in the 30 days pre-COVID-19 or post-COVID-19 and those not exposed to medications in the 30 days pre- or post-COVID-19.
The study period includes data from January 1, 2020 to November 30, 2023. We distributed this request to seven Sentinel Data Partners on February 8, 2024.
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