宫颈环扎术预防多胎妊娠早产

Cervical stitch (cerclage) for preventing preterm birth in multiple pregnancy.

作者信息

Rafael Timothy J, Berghella Vincenzo, Alfirevic Zarko

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, New York, USA.

出版信息

Cochrane Database Syst Rev. 2014 Sep 10;2014(9):CD009166. doi: 10.1002/14651858.CD009166.pub2.

Abstract

BACKGROUND

Cervical cerclage is a surgical intervention involving placing a stitch around the uterine cervix. The suture material aims to prevent cervical shortening and opening, thereby reducing the risk of preterm birth. The effectiveness and safety of this procedure in multiple gestations remains controversial.

OBJECTIVES

To assess whether the use of a cervical cerclage in multiple gestations, either at high risk of pregnancy loss based on just the multiple gestation (history-indicated cerclage), the ultrasound findings of 'short cervix' (ultrasound-indicated cerclage), or the physical exam changes in the cervix (physical exam-indicated cerclage), improves obstetrical and perinatal outcomes. The primary outcomes assessed were perinatal deaths, serious neonatal morbidity, and perinatal deaths and serious neonatal morbidity.

SEARCH METHODS

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2014) and reference lists of retrieved studies.

SELECTION CRITERIA

All randomised controlled trials (RCTs) of cervical cerclage in multiple pregnancies. Quasi-RCTs and RCTs using a cluster-randomised design were eligible for inclusion (but none were identified). Studies using a cross-over design and those presented only as abstracts were not eligible for inclusion.We included studies comparing cervical cerclage with no cervical cerclage in multiple pregnancies.Studies comparing cervical stitch versus any other preventative therapy (e.g. progesterone) in multiple pregnancies, and studies involving comparisons between different cerclage protocols (history-indicated versus ultrasound-indicated versus physical exam-indicated cerclage) were also eligible for inclusion but none were identified.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed trials for inclusion and risk of bias. Two review authors extracted data. Data were checked for accuracy.

MAIN RESULTS

We included five trials, which in total randomised 1577 women, encompassing both singleton and multiple gestations. After excluding singletons, the final analysis included 128 women, of which 122 women had twin gestations, and six women had triplet gestations. Two trials (n = 73 women) assessed history-indicated cerclage, while three trials (n = 55 women) assessed ultrasound-indicated cerclage. The five trials were judged to be of average to above average quality, with three of the trials at unclear risk regarding selection and detection biases.Concerning the primary outcomes, when outcomes for cerclage were pooled together for all indications and compared with no cerclage, there was no statistically significant differences in perinatal deaths (19.2% versus 9.5%; risk ratio (RR) 1.74, 95% confidence intervals (CI) 0.92 to 3.28, five trials, n = 262), serious neonatal morbidity (15.8% versus 13.6%; average RR 0.96, 95% CI 0.13 to 7.10, three trials, n = 116), or composite perinatal death and neonatal morbidity (40.4% versus 20.3%; average RR 1.54, 95% CI 0.58 to 4.11, three trials, n = 116).Among the secondary outcomes, there were no significant differences between the cerclage and the no cerclage groups. To name a few, there were no significant differences among the following: preterm birth less than 34 weeks (average RR 1.16, 95% CI 0.44 to 3.06, four trials, n = 83), preterm birth less than 35 weeks (average RR 1.11, 95% CI 0.58 to 2.14, four trials, n = 83), low birthweight less than 2500 g (average RR 1.10, 95% CI 0.82 to 1.48, four trials, n = 172), very low birthweight less than 1500 g (average RR 1.42, 95% CI 0.52 to 3.85, four trials, n = 172), and respiratory distress syndrome (average RR 1.70, 95% CI 0.15 to 18.77, three trials, n = 116). There were also no significant differences between the cerclage and no cerclage groups when examining caesarean section (elective and emergency) (RR 1.24, 95% CI 0.65 to 2.35, three trials, n = 77) and maternal side-effects (RR 3.92, 95% CI 0.17 to 88.67, one trial, n = 28).Examining the differences between prespecified subgroups, ultrasound-indicated cerclage was associated with an increased risk of low birthweight (average RR 1.39, 95% CI 1.06 to 1.83, Tau² = 0.01, I² = 15%, three trials, n = 98), very low birthweight (average RR 3.31, 95% CI 1.58 to 6.91, Tau² = 0, I² = 0%, three trials, n = 98), and respiratory distress syndrome (average RR 5.07, 95% CI 1.75 to 14.70, Tau² = 0, I² = 0%, three trials, n = 98). However, given the low number of trials, as well as substantial heterogeneity and subgroup differences, these data must be interpreted cautiously.No trials reported on long-term infant neurodevelopmental outcomes. There were no physical exam-indicated cerclages available for comparison among the studies included.

AUTHORS' CONCLUSIONS: This review is based on limited data from five small studies of average to above average quality. For multiple gestations, there is no evidence that cerclage is an effective intervention for preventing preterm births and reducing perinatal deaths or neonatal morbidity.

摘要

背景

宫颈环扎术是一种外科手术,通过在子宫颈周围放置缝线来防止宫颈缩短和扩张,从而降低早产风险。该手术在多胎妊娠中的有效性和安全性仍存在争议。

目的

评估在多胎妊娠中,基于多胎妊娠本身(病史指征性环扎)、超声检查发现“宫颈短”(超声指征性环扎)或宫颈体格检查变化(体格检查指征性环扎)而处于妊娠丢失高风险时,使用宫颈环扎术是否能改善产科和围产期结局。评估的主要结局为围产期死亡、严重新生儿发病率以及围产期死亡和严重新生儿发病率。

检索方法

我们检索了Cochrane妊娠与分娩组试验注册库(2014年6月30日)以及检索到的研究的参考文献列表。

入选标准

所有关于多胎妊娠宫颈环扎术的随机对照试验(RCT)。采用整群随机设计的半随机对照试验和RCT符合纳入标准(但未检索到此类研究)。采用交叉设计的研究以及仅以摘要形式呈现的研究不符合纳入标准。我们纳入了比较多胎妊娠中宫颈环扎术与未行宫颈环扎术的研究。比较多胎妊娠中宫颈缝线与任何其他预防性治疗(如孕激素)的研究,以及涉及不同环扎方案(病史指征性与超声指征性与体格检查指征性环扎)之间比较的研究也符合纳入标准,但未检索到此类研究。

数据收集与分析

两位综述作者独立评估试验是否符合纳入标准及偏倚风险。两位综述作者提取数据,并检查数据准确性。

主要结果

我们纳入了5项试验,共随机分配了1577名女性,包括单胎和多胎妊娠。排除单胎妊娠后,最终分析纳入了128名女性,其中122名女性为双胎妊娠,6名女性为三胎妊娠。两项试验(n = 73名女性)评估了病史指征性环扎,三项试验(n = 55名女性)评估了超声指征性环扎。这5项试验被判定为质量中等至中等以上,其中三项试验在选择和检测偏倚方面风险不明。关于主要结局,当将所有指征的环扎术结局合并在一起并与未行环扎术进行比较时,围产期死亡(19.2%对9.5%;风险比(RR)1.74,95%置信区间(CI)0.92至3.28,5项试验,n = 262)、严重新生儿发病率(15.8%对13.6%;平均RR 0.96,95% CI 0.13至7.10,3项试验,n = 116)或围产期死亡和新生儿发病率综合结局(40.4%对20.3%;平均RR 1.54,95% CI 0.58至4.11,3项试验,n = 116)均无统计学显著差异。在次要结局中,环扎术组与未行环扎术组之间无显著差异。例如,以下方面无显著差异:孕周小于34周的早产(平均RR 1.16,95% CI 0.44至3.06,4项试验,n = 83)、孕周小于35周的早产(平均RR 1.11,95% CI 0.58至2.14,4项试验,n = 83)、出生体重小于2500g的低体重儿(平均RR 1.10,95% CI 0.82至1.48,4项试验,n = 172)、出生体重小于1500g的极低体重儿(平均RR 1.42,95% CI 0.52至3.85,4项试验,n = 172)以及呼吸窘迫综合征(平均RR 1.70,95% CI 0.15至18.77,3项试验,n = 116)。在检查剖宫产(择期和急诊)(RR 1.24,95% CI 0.65至2.35,3项试验,n = 77)和母体副作用(RR 3.92,95% CI 0.17至88.67,1项试验,n = 28)时,环扎术组与未行环扎术组之间也无显著差异。在检查预设亚组之间的差异时,超声指征性环扎与低体重儿(平均RR 1.39,95% CI 1.06至1.83,Tau² = 0.01,I² = 15%,3项试验,n = 98)、极低体重儿(平均RR 3.31,95% CI 1.58至6.91,Tau² = 0,I² = 0%,3项试验,n = 98)和呼吸窘迫综合征(平均RR 5.07,95% CI 1.75至14.70,Tau² = 0,I² = 0%,3项试验,n = 98)风险增加相关。然而,鉴于试验数量较少,以及存在大量异质性和亚组差异,这些数据必须谨慎解读。没有试验报告长期婴儿神经发育结局。在纳入的研究中没有可供比较的体格检查指征性环扎术。

作者结论

本综述基于5项质量中等至中等以上的小型研究的有限数据。对于多胎妊娠,没有证据表明环扎术是预防早产、降低围产期死亡或新生儿发病率的有效干预措施。

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