To evaluate neonatal outcomes following SSRI exposure during pregnancy using a target trial framework.
Approach:
Study Design: Applied a target trial framework to a database linking electronic health records of mothers and newborns.
Cohort Description: Included 77,813 mother-baby dyads from Vanderbilt University Medical Center between 2006 and 2022.
Eligibility Criteria: Pregnant women with singleton pregnancies on SSRIs within 2 years before estimated date of conception.
Trial Versions: Defined two target trial versions: early-pregnancy trial (up to end of second trimester) and periconception trial (up to end of first trimester).
Treatment Groups: Participants were categorized into continuation (exposed to SSRIs during pregnancy) and discontinuation (no SSRI exposure during pregnancy).
Key Findings:
The target trial framework helps mitigate biases in observational studies.
Linking electronic health records enhances data completeness and the range of variables for analysis.
Interpretation:
The study provides a nuanced understanding of SSRI use during pregnancy and emphasizes the importance of rigorous study design.
Limitations:
Retrospective observational study design may introduce bias.
Ethical challenges limit randomized clinical trials during pregnancy.
Conclusion:
The study highlights the complexities involved in assessing neonatal outcomes related to prenatal SSRI exposure.
