Abstract：
OBJECTIVE: This meta-analysis aimed to comprehensively assess the teratogenic risk to offspring associated with continuing pregnancy after administering mifepristone and/or misoprostol during gestation.
METHODS: We conducted a systematic search of multiple databases, including PubMed, Web of Science, Embase, Cochrane, CNKI, and CBM, from their inception to February 2024, with no language restrictions. We included cohort and case-control studies that analyzed the teratogenic effects of mifepristone and/or misoprostol on fetuses and newborns. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS). The odds ratios (OR) from individual studies were combined using meta-analysis. Sensitivity testing and heterogeneity analysis were conducted.
RESULTS: A total of 13 studies were eligible for inclusion, comprising 5193 cases of congenital malformations and 12,232 controls.
CONCLUSIONS: Our findings indicated that the use of misoprostol during early pregnancy increased the risk of congenital abnormalities in offspring (OR = 2.69; 95% CI: 1.57-4.62). However, the potential teratogenic effect of mifepristone during pregnancy cannot be ruled out. Additionally, the use of mifepristone and/or misoprostol has been linked to a higher risk of certain congenital anomalies, such as hydrocephalus (OR = 3.41; 95% CI: 1.17-9.97), Möbius syndrome (OR = 26.48; 95% CI: 11.30-62.01), and terminal transverse limb defects (OR = 10.75; 95% CI: 3.93-29.41). (PROSPERO, CRD42024522093, 03182024).
METHODS: We conducted a systematic search of multiple databases, including PubMed, Web of Science, Embase, Cochrane, CNKI, and CBM, from their inception to February 2024, with no language restrictions. We included cohort and case-control studies that analyzed the teratogenic effects of mifepristone and/or misoprostol on fetuses and newborns. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS). The odds ratios (OR) from individual studies were combined using meta-analysis. Sensitivity testing and heterogeneity analysis were conducted.
RESULTS: A total of 13 studies were eligible for inclusion, comprising 5193 cases of congenital malformations and 12,232 controls.
CONCLUSIONS: Our findings indicated that the use of misoprostol during early pregnancy increased the risk of congenital abnormalities in offspring (OR = 2.69; 95% CI: 1.57-4.62). However, the potential teratogenic effect of mifepristone during pregnancy cannot be ruled out. Additionally, the use of mifepristone and/or misoprostol has been linked to a higher risk of certain congenital anomalies, such as hydrocephalus (OR = 3.41; 95% CI: 1.17-9.97), Möbius syndrome (OR = 26.48; 95% CI: 11.30-62.01), and terminal transverse limb defects (OR = 10.75; 95% CI: 3.93-29.41). (PROSPERO, CRD42024522093, 03182024).
摘要：
目的：本荟萃分析旨在全面评估妊娠期间服用米非司酮和/或米索前列醇后继续妊娠对后代的致畸风险。
方法：我们对多个数据库进行了系统搜索，包括PubMed,WebofScience,Embase,科克伦,CNKI,和CBM,从成立到2024年2月，没有语言限制。我们纳入了队列和病例对照研究，分析了米非司酮和/或米索前列醇对胎儿和新生儿的致畸作用。使用纽卡斯尔-渥太华量表（NOS）进行质量评估。使用荟萃分析将来自各个研究的优势比（OR）进行组合。进行敏感性测试和异质性分析。
结果：共有13项研究符合纳入条件，包括5193例先天性畸形和12232例对照。
结论：我们的研究结果表明，在妊娠早期使用米索前列醇增加了后代先天性畸形的风险（OR=2.69；95％CI：1.57-4.62）。然而,不能排除米非司酮在怀孕期间的潜在致畸作用。此外,米非司酮和/或米索前列醇的使用与某些先天性异常的高风险有关，如脑积水（OR=3.41；95%CI：1.17-9.97），莫比乌斯综合征（OR=26.48；95%CI：11.30-62.01），和末端横肢缺损（OR=10.75；95％CI：3.93-29.41）。(PROSPERO,CRD42024522093,03182024)。
方法：我们对多个数据库进行了系统搜索，包括PubMed,WebofScience,Embase,科克伦,CNKI,和CBM,从成立到2024年2月，没有语言限制。我们纳入了队列和病例对照研究，分析了米非司酮和/或米索前列醇对胎儿和新生儿的致畸作用。使用纽卡斯尔-渥太华量表（NOS）进行质量评估。使用荟萃分析将来自各个研究的优势比（OR）进行组合。进行敏感性测试和异质性分析。
结果：共有13项研究符合纳入条件，包括5193例先天性畸形和12232例对照。
结论：我们的研究结果表明，在妊娠早期使用米索前列醇增加了后代先天性畸形的风险（OR=2.69；95％CI：1.57-4.62）。然而,不能排除米非司酮在怀孕期间的潜在致畸作用。此外,米非司酮和/或米索前列醇的使用与某些先天性异常的高风险有关，如脑积水（OR=3.41；95%CI：1.17-9.97），莫比乌斯综合征（OR=26.48；95%CI：11.30-62.01），和末端横肢缺损（OR=10.75；95％CI：3.93-29.41）。(PROSPERO,CRD42024522093,03182024)。
