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  3. Antipsychotic drug use in pregnancy: high dimensional, propensity matched, population based cohort study
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Research

Antipsychotic drug use in pregnancy: high dimensional, propensity matched, population based cohort study

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2298 (Published 13 May 2015) Cite this as: BMJ 2015;350:h2298
  1. Simone N Vigod, scientist; assistant professor123,
  2. Tara Gomes, scientist2,
  3. Andrew S Wilton, analyst2,
  4. Valerie H Taylor, psychiatrist-in-chief; associate professor13,
  5. Joel G Ray, professor24
  1. 1Women’s College Research Institute; Department of Psychiatry, University of Toronto, Toronto, Ontario M5S 1B2, Canada
  2. 2Institute for Clinical Evaluative Sciences, Toronto, Ontario M4N 3M5
  3. 3Department of Psychiatry, Women’s College Hospital; University of Toronto, Toronto, Ontario
  4. 4Departments of Medicine and Obstetrics and Gynaecology, St Michael’s Hospital, University of Toronto, Toronto, Ontario M5B 1W8
  1. Correspondence to: S N Vigod simone.vigod{at}wchospital.ca
  • Accepted 22 March 2015

Abstract

Objective To evaluate maternal medical and perinatal outcomes associated with antipsychotic drug use in pregnancy.

Design High dimensional propensity score (HDPS) matched cohort study.

Setting Multiple linked population health administrative databases in the entire province of Ontario, Canada.

Participants Among women who delivered a singleton infant between 2003 and 2012, and who were eligible for provincially funded drug coverage, those with ≥2 consecutive prescriptions for an antipsychotic medication during pregnancy, at least one of which was filled in the first or second trimester, were selected. Of these antipsychotic drug users, 1021 were matched 1:1 with 1021 non-users by means of a HDPS algorithm.

Main outcome measures The main maternal medical outcomes were gestational diabetes, hypertensive disorders of pregnancy, and venous thromboembolism. The main perinatal outcomes were preterm birth (<37 weeks), and a birth weight <3rd or >97th centile. Conditional Poisson regression analysis was used to generate rate ratios and 95% confidence intervals, adjusting for additionally prescribed non-antipsychotic psychotropic medications.

Results Compared with non-users, women prescribed an antipsychotic medication in pregnancy did not seem to be at higher risk of gestational diabetes (rate ratio 1.10 (95% CI 0.77 to 1.57)), hypertensive disorders of pregnancy (1.12 (0.70 to 1.78)), or venous thromboembolism (0.95 (0.40 to 2.27)). The preterm birth rate, though high among antipsychotic users (14.5%) and matched non-users (14.3%), was not relatively different (rate ratio 0.99 (0.78 to 1.26)). Neither birth weight <3rd centile or >97th centile was associated with antipsychotic drug use in pregnancy (rate ratios 1.21 (0.81 to 1.82) and 1.26 (0.69 to 2.29) respectively).

Conclusions Antipsychotic drug use in pregnancy had minimal evident impact on important maternal medical and short term perinatal outcomes. However, the rate of adverse outcomes is high enough to warrant careful assessment of maternal and fetal wellbeing among women prescribed an antipsychotic drug in pregnancy.

Footnotes

  • Contributors: SNV, TG, VHT, and JGR conceived of the study. All authors performed data analysis and interpretation. SNV drafted the manuscript; SNV, TG, ASW, VHT, and JGR revised the manuscript; and all authors approval the final version. SNV is guarantor for the study.

  • Funding: This study was supported by a grant from the Canadian Institutes of Health Research (CIHR). It was also supported by the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). The opinions, results, and conclusions reported in this paper are those of the authors and are independent from the funding sources. No endorsement by ICES or the Ontario MOHLTC is intended or should be inferred.

  • Role of the study sponsors: The study sponsors provided the operating costs and infrastructure to support the research. No funding bodies had any role in the study design, data collection, analysis, decision to publish, or preparation of the manuscript.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that no authors (nor their institutions) received payments for their efforts on this project. Unrelated to this project, SNV has received a one-time consulting fee from Multi-Dimensional Health Care (MDH) consulting for the development of continuing healthcare activities related to perinatal mental health; VHT receives funding from Bristol-Myers Squibb for an investigator initiated study and has been a speaker for Astra-Zeneca, Bristol-Myers Squibb, Eli Lilly, and Lundbeck. The remaining authors declare no competing interests: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.

  • Transparency: SNV affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained. All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

  • Data sharing: ICES is named as a prescribed entity under Section 45(1) of Ontario’s Personal Health Information Protection Act, 2004 (PHIPA). As a requirement of having this status in PHIPA, ICES policies, practices and procedures are reviewed and approved by the Ontario Information and Privacy Commissioner. Access to raw data is governed by confidentiality agreements between ICES and independent investigators as per PHIPHA guidelines.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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