A retrospective analysis of outcomes from post-approval safety studies highlights the need for standardized evaluation in pregnancy, suggesting improved data comparability.
Key Points
The aim is to summarize outcomes assessed in post-approval safety studies during pregnancy and evaluate how study characteristics influence these outcomes.
Query of post-approval safety studies registered on HMA-EMA Catalogue of Real-world Data Studies
Evaluation of protocols and outcomes across included studies
Assessment of factors influencing outcome reporting
Out of 3100 studies, 30 met eligibility for inclusion, showing stillbirth in 25 studies and congenital malformations in 24 studies.
Study characteristics influenced outcome variability, with no universal outcomes evaluated across all studies.
Sample sizes were generally low with a median of 110, limiting the power to analyze key outcomes like stillbirth.