本研究旨在确定手术流产前直至妊娠13+6周的最佳宫颈预激方案。
Embase,MEDLINE,并在Cochrane图书馆搜索了截至2020年2月的出版物。任何正在进行或错过的试验都会咨询专家。
这项研究包括2000年以后以英文发表的随机对照试验,比较了以下方面:(1)米非司酮和米索前列醇,安慰剂,或没有引发;(2)不同剂量的米非司酮或米索前列醇;(3)引发和流产之间的不同间隔;或(4)米索前列醇给药的不同途径。
使用Cochrane协作检查表对随机对照试验的偏倚风险进行评估,和数据在ReviewManager5.3中进行了荟萃分析。使用Mantel-Haenszel方法将二分结果分析为风险比,和连续结果使用逆方差法分析为平均差。当没有实质性异质性(I2<50%)时,使用固定效应模型,随机效应模型用于中度异质性(I2≤50%和<80%),当存在高度异质性(I2≥80%)时,证据未汇总。亚组分析在可能的情况下基于奇偶校验进行。使用建议分级评估来评估证据的总体质量,发展和评价。
共纳入18项随机对照试验(n=8538),并显示以下内容:不完全流产率降低(风险比=0.44;95%置信区间,0.21-0.9)和扩张子宫颈所需的力(平均差=-7.08N;95%置信区间,-11.67至-2.49)和术前出血增加(风险比=5.90;95%置信区间,5.08-6.86)使用米索前列醇与未引发相比;与流产前3小时相比,在流产前1小时舌下给予米索前列醇的术前出血减少(风险比=0.14;95%置信区间,0.03-0.56);和扩大子宫颈所需的力增加(平均差=14.3N;95%置信区间,2.13-26.47),与流产前48小时相比,在流产前24小时给予米非司酮。在纳入的研究中,证据基础的质量受到事件发生率低和偏倚风险的限制。
米索前列醇宫颈灌注可降低妊娠早期手术流产时宫颈扩张所需的力,并降低不完全流产的风险。与临床专业知识一起考虑,该证据支持在妊娠早期手术流产前使用400µg米索前列醇或常规宫颈预涂,如果米索前列醇不能使用,200mg口服米非司酮。
This study aimed to determine the optimal cervical priming regimen before surgical abortion up to and including 13+6 weeks\' gestation.
Embase, MEDLINE, and the Cochrane Library were searched for publications up to February 2020. Experts were consulted for any ongoing or missed trials.
This study included randomized controlled trials published in English after 2000 that compared the following: (1) mifepristone and
misoprostol against each other, placebo, or no priming; (2) different doses of mifepristone or
misoprostol; (3) different intervals between priming and abortion; or (4) different routes of
misoprostol administration.
Risk of bias was assessed using the Cochrane Collaboration checklist for randomized controlled trials, and data were metaanalyzed in Review Manager 5.3. Dichotomous outcomes were analyzed as risk ratios using the Mantel-Haenszel method, and continuous outcomes were analyzed as mean differences using the inverse variance method. Fixed effects models were used when there was no substantial heterogeneity (I2<50%), random effects models were used for moderate heterogeneity (I2≤50% and <80%), and evidence was not pooled when there was high heterogeneity (I2≥80%). Subgroup analyses were undertaken based on parity where available. The overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.
A total of 18 randomized controlled trials (n=8538) were included and showed the following: decreased incomplete abortion rate (risk ratio=0.44; 95% confidence interval, 0.21-0.9) and force required to dilate the cervix (mean difference= -7.08 N; 95% confidence interval, -11.67 to -2.49) and increased preoperative bleeding (risk ratio=5.90; 95% confidence interval, 5.08-6.86) with misoprostol compared with no priming; decreased preoperative bleeding when sublingual
misoprostol was given 1 hour before abortion compared with 3 hours before (risk ratio=0.14; 95% confidence interval, 0.03-0.56); and increased force required to dilate the cervix (mean difference=14.3 N; 95% confidence interval, 2.13-26.47) when mifepristone was given 24 hours before abortion compared with 48 hours before. The quality of the evidence base was limited by low event rates and risk of bias in included studies.
Cervical priming with misoprostol decreases the force needed to dilate the cervix for first trimester surgical abortion and reduces the risk of incomplete abortion. Considered alongside clinical expertise, this evidence supports the use of routine cervical priming before first trimester surgical abortion with 400 µg misoprostol or, if
misoprostol cannot be used, 200 mg oral mifepristone.