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有剖宫产史的女性足月引产方法。

Methods of term labour induction for women with a previous caesarean section.

作者信息

West Helen M, Jozwiak Marta, Dodd Jodie M

机构信息

Institute of Psychology, Health and Society, The University of Liverpool, Liverpool, UK.

出版信息

Cochrane Database Syst Rev. 2017 Jun 9;6(6):CD009792. doi: 10.1002/14651858.CD009792.pub3.

Abstract

BACKGROUND

Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013.

OBJECTIVES

To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth.

SEARCH METHODS

We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies.

SELECTION CRITERIA

Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy.

MAIN RESULTS

Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. Foley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Double-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported. Oral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported. Vaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. 80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Vaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.

AUTHORS' CONCLUSIONS: RCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.High-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.

摘要

背景

有剖宫产史的女性发生子宫破裂的风险增加,对于随后需要引产的女性而言,尚不清楚哪种方法更可取以避免不良结局。这是对2013年发表的一篇综述的更新。

目的

评估既往有剖宫产史的女性采用不同引产方法的益处和危害。

检索方法

我们检索了Cochrane妊娠与分娩试验注册库(2016年8月31日)以及检索到的研究的参考文献列表。

入选标准

随机对照试验(RCT),比较晚期妊娠宫颈成熟或引产的任何方法与安慰剂/不治疗或其他方法,研究对象为既往有剖宫产史且下次妊娠需要引产的女性。

数据收集与分析

两位综述作者独立评估研究是否纳入及试验质量,提取数据并检查其准确性。

主要结果

本更新综述纳入了8项研究(707名女性及婴儿的数据)。由于各研究比较的引产方法不同,无法进行Meta分析。所有纳入研究均至少存在一项设计缺陷(即缺乏盲法、样本流失、其他偏倚或报告偏倚)。一项研究因安全问题提前终止。阴道用PGE2与静脉滴注缩宫素(一项试验,42名女性):剖宫产(风险比(RR)0.67,95%置信区间(CI)0.22至2.03,证据质量等级低)、严重新生儿发病率或围产期死亡(RR 3.00,95% CI 0.13至69.70,证据质量等级低)、严重孕产妇发病率或死亡(RR 3.00,95% CI 0.13至69.70,证据质量等级低)方面无明显差异。各研究报告的次要结局组间也无明显差异。未报告24小时内未实现阴道分娩及伴有胎心率变化的子宫过度刺激的GRADE结局。阴道用米索前列醇与静脉滴注缩宫素(一项试验,3名女性):该试验提前终止,因为一名接受米索前列醇的女性发生子宫破裂(RR 3.67,95% CI 0.16至84.66),一名发生子宫裂开。未报告其他结局(包括GRADE结局)。Foley导尿管与静脉滴注缩宫素(一项试验,53名女性的亚组):24小时内未实现阴道分娩(RR 1.47,95% CI 0.89至2.44,证据质量等级低)、伴有胎心率变化的子宫过度刺激(RR 3.11,95% CI 0.13至73.09,证据质量等级低)及剖宫产(RR 0.93,95% CI 0.45至1.92,证据质量等级低)方面组间无明显差异。各研究报告的次要结局组间也无明显差异。未报告以下GRADE结局:严重新生儿发病率或围产期死亡,以及严重孕产妇发病率或死亡。双球囊导管与阴道用PGE2(一项试验,26名女性的亚组):剖宫产方面无明显差异(RR 0.97,95% CI 0.41至2.32,证据质量等级极低)。未报告24小时内未实现阴道分娩、伴有胎心率变化 的子宫过度刺激、严重新生儿发病率或围产期死亡,以及严重孕产妇发病率或死亡。口服米非司酮与Foley导尿管(一项试验,107名女性):未报告主要/GRADE结局。使用米非司酮引产的女性中需要缩宫素加强宫缩的较少(RR 0.54,95% CI 0.38至0.76)。接受米非司酮的女性中子宫破裂病例略少,但组间差异不明显(RR 0.29,95% CI 0.08至1.02)。未报告其他次要结局。阴道用单硝酸异山梨酯(IMN)与Foley导尿管(一项试验,80名女性):使用IMN引产的女性中24小时内实现阴道分娩的较少(RR 2.62,95% CI 1.32至5.21,证据质量等级低)。剖宫产女性数量组间无差异(RR 1.00,95% CI 0.39至2.59,证据质量等级极低)。使用IMN引产的女性中需要缩宫素加强宫缩的较多(RR 1.65,95% CI 1.17至2.32)。其他报告的次要结局组间无明显差异。未报告以下GRADE结局:伴有胎心率变化的子宫过度刺激、严重新生儿发病率或围产期死亡,以及严重孕产妇发病率或死亡。80 mL与30 mL Foley导尿管(一项试验,154名女性):主要结局方面组间无明显差异:24小时内未实现阴道分娩(RR 1.05,95% CI 0.91至1.20,证据质量等级中等)及剖宫产(RR 1.05,95% CI 0.89至1.24,证据质量等级中等)。然而,使用30 mL Foley导尿管引产的女性中需要缩宫素加强宫缩的较多(RR 0.81,95% CI 0.66至0.98)。其他报告的次要结局组间无明显差异。未报告多项GRADE结局:伴有胎心率变化的子宫过度刺激、严重新生儿发病率或围产期死亡,以及严重孕产妇发病率或死亡。阴道用PGE2阴道栓与阴道用PGE2片剂(一项试验,200名女性):剖宫产或任何报告的次要结局组间无差异。未报告多项GRADE结局:24小时内未实现阴道分娩、伴有胎心率变化的子宫过度刺激、严重新生儿发病率或围产期死亡,以及严重孕产妇发病率或死亡。

作者结论

关于既往有剖宫产史女性引产方法的RCT证据不足,且研究的样本量不足以检测许多结局的临床相关差异。多项研究报告的预设结局很少,婴儿结局的报告尤其匮乏。由于不精确性和研究设计缺陷,证据质量的GRADE水平为中等至极低。高质量、样本量充足的RCT是确定既往有剖宫产史女性引产最佳方法的最佳途径。然而,由于需要大量样本以研究罕见但严重的不良结局(如子宫破裂)的风险,此类试验不太可能开展。观察性研究(队列研究),包括不同的宫颈成熟方法,可能是最佳替代方案。研究可比较被认为能有效引产且严重伤害风险低的方法,并报告本综述中列出的结局。

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