Observational studyJournal of clinical psychopharmacology
Reproductive Safety of Trazodone After Maternal Exposure in Early Pregnancy: A Comparative ENTIS Cohort Study.
Observational study in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- The effects of trazodone exposure during pregnancy on fetal outcomes: a systematic review.European journal of clinical pharmacology · 2025Pooled it
- A narrative review on trazodone as a multimodal and multifunctional antidepressant: clinical relevance of formulations, dosing, and pharmacokinetic/pharmacodynamic targets.Annals of general psychiatry · 2026Review
- Expert consensus on the use of trazodone in patients with major depressive disorder: results from a European Delphi panel.European psychiatry : the journal of the Association of European Psychiatrists · 2026Article
- Another prospective study on the safety of ondansetron for nausea and vomiting of pregnancy: addressing ongoing concerns.Frontiers in pharmacology · 2026Article
- Review
- Observational
- Depression Treatment in Pregnancy: Is It Safe, or Is It Not?International journal of environmental research and public health · 2024Review
- Role of trazodone in treatment of major depressive disorder: an update.Annals of general psychiatry · 2023Review
- Consensus Panel Recommendations for the Pharmacological Management of Pregnant Women with Depressive Disorders.International journal of environmental research and public health · 2023Article
- Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project.Drug safety · 2023Review
- Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes.Frontiers in drug safety and regulation · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 8 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
PURPOSE/
backgroundTrazodone is indicated for the treatment of major depressive disorder, but more frequently prescribed off-label at lower doses for insomnia in women of childbearing age. The aim of this study was to assess the risks linked to trazodone exposure during pregnancy for which limited safety data are available. METHODS/PROCEDURES: This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to trazodone in early pregnancy against those in a reference group of women exposed to a selective serotonin reuptake inhibitors (SSRIs) between 1996 and 2021. FINDINGS/
resultsThe sample included 221 trazodone and 869 SSRI-exposed pregnancies. Exposure to trazodone in the first trimester was not associated with a significant difference in the risk of major congenital anomalies (trazodone [1/169, 0.6%]; SSRI [19/730, 2.6%]; adjusted odds ratio, 0.2; 95% confidence interval, 0.03-1.77). The cumulative incidences of live birth were 61% and 73% in the trazodone and reference group, respectively (25% vs 18% for pregnancy loss and 14% vs 10% for pregnancy termination). Trazodone exposure was not associated with a significantly increased risk of pregnancy termination and pregnancy loss. The rate of small for gestational age infants did not differ between the groups. IMPLICATIONS/
conclusionsThis study did not reveal a significant difference in the risk of major congenital anomalies after first trimester exposure to trazodone, compared with SSRI exposure. Although this study is the largest so far, these results call for confirmation through further studies.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.