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Intraocular pressure–lowering medications during pregnancy and risk of neonatal adverse outcomes: a propensity score analysis using a large database
  1. Yohei Hashimoto1,2,
  2. Nobuaki Michihata3,
  3. Hayato Yamana3,
  4. Daisuke Shigemi2,
  5. Kojiro Morita2,4,
  6. Hiroki Matsui2,
  7. Hideo Yasunaga2,
  8. Makoto Aihara1
  1. 1 Department of Ophthalmology, The University of Tokyo, Bunkyo-ku,Japan
  2. 2 Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Bunkyo-ku,Japan
  3. 3 Department of Health Services Research, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku,Japan
  4. 4 Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan
  1. Correspondence to Yohei Hashimoto, Department of Ophthalmology, Graduate School of Medicine, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; youhashimoto-tky{at}


Background/Aims To investigate the association between exposure to intraocular pressure (IOP)–lowering medications during pregnancy and neonatal adverse outcomes.

Methods This retrospective, cohort study used the JMDC Claims Database (JMDC, Tokyo, Japan), 2005–2018. We extracted data on pregnant women with glaucoma, including dispensation of (1) any IOP-lowering medications, (2) only prostaglandin analogues (PGs) and 3) only beta-blockers, during the first trimester. We compared frequency of congenital anomalies (CA), preterm birth (PB), low birth weight (LBW) and the composite outcome of these three measures, between the women with and without IOP-lowering medications. We calculated propensity scores (PSs) using logistic regression in which use of IOP-lowering medications was regressed against known confounders (disorders during pregnancy and other chronic comorbidities). We then conducted logistic regression in which neonatal adverse outcomes were regressed against use of IOP-lowering medications with adjustment for the PS.

Results We identified 826 eligible women, 91 (11%) of whom had received any IOP-lowering medications. CA occurred in 9.9% and 6.4%, PB in 2.2% and 4.5%, LBW in 9.9% and 6.0% and composite outcome in 17.6% and 13.3% of mothers with and without IOP-lowering medications, respectively. After adjustment for PS, IOP-lowering medications were not significantly associated with more frequent CA (adjusted OR (aOR), 1.43; 95% CI, 0.66 to 3.12), PB (aOR, 0.45; 95% CI, 0.10 to 1.97), LBW (aOR, 2.11; 95% CI, 0.98 to 4.57) or composite outcome (aOR, 1.40; 95% CI, 0.78 to 2.53). Results were similar regarding PGs only and beta-blockers only.

Conclusions IOP-lowering medications during the first trimester were not significantly associated with increase in CA, PB or LBW.

  • Glaucoma
  • Epidemiology
  • Drugs

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  • Current affiliation The current affiliation of Kojiro Morita: Department of Health Services Research, Faculty of Medicine, University of Tsukuba and Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo.

  • Contributors YH had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: YH, HY, DS, KM, HY and MA. Acquisition, analysis and interpretation of data: YH, HY, HM and HY. Drafting of the manuscript: YH, NM, HY, DS, HY and MA. Critical revision of the manuscript for important intellectual content: YH. Statistical analysis: YH, HY, DS, KM and HY. Obtained funding: HY. Administrative, technical or material support: none. Study supervision: HY and MA.

  • Funding This work was supported by grants from the Ministry of Health, Labour and Welfare, Japan (19AA2007) and the Ministry of Education, Culture, Sports, Science and Technology, Japan (17H04141 and 17H05077).

  • Competing interests None declared.

  • Ethics approval The Institutional Review Board of the University of Tokyo approved this study (10862-(1)). We waived the need for informed consent because of the anonymous nature of the database.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data may be obtained from a third party and are not publicly available.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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