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COVID-19 in Pregnancy & Drug Utilization, Disease Severity, Adverse Neonatal Outcomes, and Adverse Maternal Outcomes

Basic Details
Status
Complete
Last Updated
Tuesday, December 31, 2024
Original Posting Date
Health Outcome(s)
adverse maternal outcomes
adverse neonatal outcomes
disease severity
drug utilization
Purpose
Non-Regulatory Public Health
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

The FDA conducted analyses in the Sentinel System to describe medication use and evaluate the risk of adverse infant and maternal outcomes among pregnant individuals with coronavirus disease 2019 (COVID-19). These analyses supported an international collaboration funded by the European Medicines Agency (EMA) to study COVID-19 and pregnancy, known as “COVID-19 infectiOn aNd medicineS In pregnancy” (CONSIGN)1 . The CONSIGN study, which drafted a protocol to examine the natural history of COVID-19 disease in pregnant people, was implemented across data sources in eight European countries. This Sentinel study implemented the following three CONSIGN protocol aims:

  1. 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.
  2. 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.
  3. 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.

Sentinel results indicated that medications used for potential COVID-19 treatment varied over time. The analyses did not find an increased risk of adverse maternal or infant outcomes in pregnancies with COVID-19 compared to those without COVID-19. However, among less than 5% of pregnancies with severe COVID-19 in the third trimester, a higher proportion of low birth weight was observed. Additionally, higher rates of preterm birth and caesarean section were noted among pregnancies with severe COVID-19. These findings may be challenging to interpret due to temporal changes in COVID-19 severity, treatment, and prevention advancements. The results of the Sentinel analyses contributed to a meta-analysis conducted across ten healthcare data sources in Europe, the United States, and Canada.

Analytic Code Link(s) (3)
Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis
Result(s) (4)
Medication Use Among Pregnant Individuals With COVID-19: A Descriptive Analysis Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis
Related Publication(s) and/or Presentation(s) (5)
Presentation: Describing Prenatal Exposures and Evaluating Maternal and Infant Outcomes in Sentinel Presentation: Characterizing Medication Use Among Pregnancies with COVID-19 in the Sentinel System Presentation: Characterizing Medication Use Patterns Among Pregnant and Non-Pregnant Patients with COVID-19 in the Sentinel System Presentation: Comparing the Risk of Adverse Infant Outcomes Among Pregnancies with and without COVID-19 in the Sentinel System Presentation: Patterns of Prescribing and Dispensing Medicines Among Non-Hospitalized Pregnant Women with COVID-19: a Prospective Meta-Analysis Pooling Findings from Healthcare Databases in Europe and North America
Link(s)
Sentinel Methods Project: COVID-19 Pregnancy Study Implementation