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KMID : 1143220210640040364
Obstetrics & Gynecology Science
2021 Volume.64 No. 4 p.364 ~ p.373
The rates of major malformations after gestational exposure to isotretinoin: a systematic review and meta-analysis
Choi Eun-Jeong

Kim Nae-Ry
Kwak Ho-Seok
Han Hae-Ji
Chun Kyoung-Chul
Kim Young-Ah
Koh Jae-Whoan
Han Jung-Yeol
Joo Sung-Hong
Lee Ji-Sung
Koren Gideon
Abstract
Objective: Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis.

Methods: Eligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis of odd ratios among controlled studies were performed using Review Manager version 5.3.

Results: Ten eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MM weighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible for the meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooled odds ratio of MM for isotretinoin exposure was significantly lower at 1.04.

Conclusion: The current rate of MM in isotretinoin-exposed women was substantially lower after 2006.
KEYWORD
Isotretinoin, Congenital malformations, Pregnancy, Meta-analysis, Systematic review
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