EFFECT OF TRIMESTER OF PRENATAL ANTIDEPRESSANT EXPOSURE ON THE RISK OF ADVERSE BIRTH AND PREGNANCY OUTCOMES: A RETROSPECTIVE COHORT STUDY USING REAL WORLD ELECTRONIC MEDICAL RECORDS
Author(s)
Fatimah Alyami, BSPharm, MS, PhD.1, Pam Heaton, BSPharm, FAPhA, PhD.2, Ana L. Hincapie, MS, PhD3, Marepalli B Rao, MS, PhD4, Patricia Wigle, Pharm.D., BCPS, BCACP, FCCP3, Jeff Jianfei Guo, B.Pharm, PhD3.
1Center for Health Technology Assessment, Riyadh, Saudi Arabia, 2University of Toledo, Toledo, OH, USA, 3James L Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA, 4College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
1Center for Health Technology Assessment, Riyadh, Saudi Arabia, 2University of Toledo, Toledo, OH, USA, 3James L Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA, 4College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
OBJECTIVES: To determine the effect of the trimester of antidepressant exposure during pregnancy on the risk of adverse birth and pregnancy outcomes among women with mental health disorders, using real-world electronic medical records (EMR).
METHODS: We conducted an observational retrospective cohort study using University of Cincinnati Medical Center Hospitals EMR (June 2012-November 2021). Pregnant women aged 15-55 years diagnosed with depression, anxiety, fibromyalgia, sleep, or other mental health disorders and exposed to antidepressants during pregnancy were identified using ICD-9/ICD-10 codes. Exposure was classified by trimester: first (last menstrual period [LMP]-week 13), second (weeks 14-27), or third (week 28-delivery). Propensity score (PS)-adjusted logistic regression estimated odds ratios (ORs) with 95% confidence intervals (CIs) for adverse outcomes by trimester; a generalized estimating equation (GEE) model accounted for multiple outcomes per woman.
RESULTS: Among 1,191 exposed women, most were exposed during the third trimester (86.56%), compared with the second (8.82%) and first (4.62%). No statistically significant associations were observed between trimester of exposure and adverse birth or pregnancy outcomes. For any adverse outcome, PS-adjusted ORs were 0.900 (95% CI, 0.373-2.169) for second versus first trimester and 1.217 (0.576-2.571) for third versus first. The multivariate GEE model yielded ORs of 0.871 (0.500-1.517) and 1.032 (0.651-1.636), respectively. Findings were similarly non-significant when maternal and neonatal outcomes were assessed separately.
CONCLUSIONS: In this real-world EMR cohort, later versus earlier trimester antidepressant exposure during pregnancy was not significantly associated with an increased risk of adverse birth or pregnancy outcomes. These findings may help inform treatment decisions for pregnant women with mental health disorders. Further studies examining the duration and timing of prenatal antidepressant exposure on neonatal outcomes are warranted.
METHODS: We conducted an observational retrospective cohort study using University of Cincinnati Medical Center Hospitals EMR (June 2012-November 2021). Pregnant women aged 15-55 years diagnosed with depression, anxiety, fibromyalgia, sleep, or other mental health disorders and exposed to antidepressants during pregnancy were identified using ICD-9/ICD-10 codes. Exposure was classified by trimester: first (last menstrual period [LMP]-week 13), second (weeks 14-27), or third (week 28-delivery). Propensity score (PS)-adjusted logistic regression estimated odds ratios (ORs) with 95% confidence intervals (CIs) for adverse outcomes by trimester; a generalized estimating equation (GEE) model accounted for multiple outcomes per woman.
RESULTS: Among 1,191 exposed women, most were exposed during the third trimester (86.56%), compared with the second (8.82%) and first (4.62%). No statistically significant associations were observed between trimester of exposure and adverse birth or pregnancy outcomes. For any adverse outcome, PS-adjusted ORs were 0.900 (95% CI, 0.373-2.169) for second versus first trimester and 1.217 (0.576-2.571) for third versus first. The multivariate GEE model yielded ORs of 0.871 (0.500-1.517) and 1.032 (0.651-1.636), respectively. Findings were similarly non-significant when maternal and neonatal outcomes were assessed separately.
CONCLUSIONS: In this real-world EMR cohort, later versus earlier trimester antidepressant exposure during pregnancy was not significantly associated with an increased risk of adverse birth or pregnancy outcomes. These findings may help inform treatment decisions for pregnant women with mental health disorders. Further studies examining the duration and timing of prenatal antidepressant exposure on neonatal outcomes are warranted.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH193
Topic
Epidemiology & Public Health, Study Approaches
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Mental Health (including addiction), Reproductive & Sexual Health