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 Maternal 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.
The goals of this analysis were to complete the following objectives: A) to estimate the prevalence of adverse infant outcomes by trimester of COVID-19 identification and by COVID-19 severity among pregnant patients with COVID-19; B) to compare rates of adverse infant outcomes among pregnant patients with COVID-19 to pregnant patients without COVID-19 using a 1:1 propensity score (PS)-matched analysis; and C) to evaluate the impact of medications used to treat COVID-19 on adverse infant outcomes by assessing incidence of adverse infant 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 December 31, 2022. We distributed this request to four Sentinel Data Partners on June 30, 2023.
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