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足月(37周及以上)胎膜早破时计划早产与期待治疗(等待)的比较。

Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more).

作者信息

Middleton Philippa, Shepherd Emily, Flenady Vicki, McBain Rosemary D, Crowther Caroline A

机构信息

Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, Women's and Children's Hospital, 72 King William Road, Adelaide, South Australia, Australia, 5006.

ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, South Australia, Australia, 5006.

出版信息

Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.

Abstract

BACKGROUND

Prelabour rupture of membranes (PROM) at term is managed expectantly or by planned early birth. It is not clear if waiting for birth to occur spontaneously is better than intervening, e.g. by inducing labour.

OBJECTIVES

The objective of this review is to assess the effects of planned early birth (immediate intervention or intervention within 24 hours) when compared with expectant management (no planned intervention within 24 hours) for women with term PROM on maternal, fetal and neonatal outcomes.

SEARCH METHODS

We searched Cochrane Pregnancy and Childbirth's Trials Register (9 September 2016) and reference lists of retrieved studies.

SELECTION CRITERIA

Randomised or quasi-randomised controlled trials of planned early birth compared with expectant management (either in hospital or at home) in women with PROM at 37 weeks' gestation or later.

DATA COLLECTION AND ANALYSIS

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

MAIN RESULTS

Twenty-three trials involving 8615 women and their babies were included in the update of this review. Ten trials assessed intravenous oxytocin; 12 trials assessed prostaglandins (six trials in the form of vaginal prostaglandin E2 and six as oral, sublingual or vaginal misoprostol); and one trial each assessed Caulophyllum and acupuncture. Overall, three trials were judged to be at low risk of bias, while the other 20 were at unclear or high risk of bias.Primary outcomes: women who had planned early birth were at a reduced risk of maternal infectious morbidity (chorioamnionitis and/or endometritis) than women who had expectant management following term prelabour rupture of membranes (average risk ratio (RR) 0.49; 95% confidence interval (CI) 0.33 to 0.72; eight trials, 6864 women; Tau² = 0.19; I² = 72%; low-quality evidence), and their neonates were less likely to have definite or probable early-onset neonatal sepsis (RR 0.73; 95% CI 0.58 to 0.92; 16 trials, 7314 infants;low-quality evidence). No clear differences between the planned early birth and expectant management groups were seen for the risk of caesarean section (average RR 0.84; 95% CI 0.69 to 1.04; 23 trials, 8576 women; Tau² = 0.10; I² = 55%; low-quality evidence); serious maternal morbidity or mortality (no events; three trials; 425 women; very low-quality evidence); definite early-onset neonatal sepsis (RR 0.57; 95% CI 0.24 to 1.33; six trials, 1303 infants; very low-quality evidence); or perinatal mortality (RR 0.47; 95% CI 0.13 to 1.66; eight trials, 6392 infants; moderate-quality evidence).

SECONDARY OUTCOMES

women who had a planned early birth were at a reduced risk of chorioamnionitis (average RR 0.55; 95% CI 0.37 to 0.82; eight trials, 6874 women; Tau² = 0.19; I² = 73%), and postpartum septicaemia (RR 0.26; 95% CI 0.07 to 0.96; three trials, 263 women), and their neonates were less likely to receive antibiotics (average RR 0.61; 95% CI 0.44 to 0.84; 10 trials, 6427 infants; Tau² = 0.06; I² = 32%). Women in the planned early birth group were more likely to have their labour induced (average RR 3.41; 95% CI 2.87 to 4.06; 12 trials, 6945 women; Tau² = 0.05; I² = 71%), had a shorter time from rupture of membranes to birth (mean difference (MD) -10.10 hours; 95% CI -12.15 to -8.06; nine trials, 1484 women; Tau² = 5.81; I² = 60%), and their neonates had lower birthweights (MD -79.25 g; 95% CI -124.96 to -33.55; five trials, 1043 infants). Women who had a planned early birth had a shorter length of hospitalisation (MD -0.79 days; 95% CI -1.20 to -0.38; two trials, 748 women; Tau² = 0.05; I² = 59%), and their neonates were less likely to be admitted to the neonatal special or intensive care unit (RR 0.75; 95% CI 0.66 to 0.85; eight trials, 6179 infants), and had a shorter duration of hospital (-11.00 hours; 95% CI -21.96 to -0.04; one trial, 182 infants) or special or intensive care unit stay (RR 0.72; 95% CI 0.61 to 0.85; four trials, 5691 infants). Women in the planned early birth group had more positive experiences compared with women in the expectant management group.No clear differences between groups were observed for endometritis; postpartum pyrexia; postpartum antibiotic usage; caesarean for fetal distress; operative vaginal birth; uterine rupture; epidural analgesia; postpartum haemorrhage; adverse effects; cord prolapse; stillbirth; neonatal mortality; pneumonia; Apgar score less than seven at five minutes; use of mechanical ventilation; or abnormality on cerebral ultrasound (no events).None of the trials reported on breastfeeding; postnatal depression; gestational age at birth; meningitis; respiratory distress syndrome; necrotising enterocolitis; neonatal encephalopathy; or disability at childhood follow-up.In subgroup analyses, there were no clear patterns of differential effects for method of induction, parity, use of maternal antibiotic prophylaxis, or digital vaginal examination. Results of the sensitivity analyses based on trial quality were consistent with those of the main analysis, except for definite or probable early-onset neonatal sepsis where no clear difference was observed.

AUTHORS' CONCLUSIONS: There is low quality evidence to suggest that planned early birth (with induction methods such as oxytocin or prostaglandins) reduces the risk of maternal infectious morbidity compared with expectant management for PROM at 37 weeks' gestation or later, without an apparent increased risk of caesarean section. Evidence was mainly downgraded due to the majority of studies contributing data having some serious design limitations, and for most outcomes estimates were imprecise.Although the 23 included trials in this review involved a large number of women and babies, the quality of the trials and evidence was not high overall, and there was limited reporting for a number of important outcomes. Thus further evidence assessing the benefits or harms of planned early birth compared with expectant management, considering maternal, fetal, neonatal and longer-term childhood outcomes, and the use of health services, would be valuable. Any future trials should be adequately designed and powered to evaluate the effects on short- and long-term outcomes. Standardisation of outcomes and their definitions, including for the assessment of maternal and neonatal infection, would be beneficial.

摘要

背景

足月胎膜早破(PROM)的处理方式为期待治疗或计划早期分娩。目前尚不清楚等待自然分娩是否优于干预措施,如引产。

目的

本综述的目的是评估对于足月胎膜早破的女性,与期待治疗(24小时内无计划干预)相比,计划早期分娩(立即干预或24小时内干预)对孕产妇、胎儿和新生儿结局的影响。

检索方法

我们检索了Cochrane妊娠与分娩试验注册库(2016年9月9日)以及检索到的研究的参考文献列表。

入选标准

妊娠37周及以后胎膜早破的女性中,比较计划早期分娩与期待治疗(在医院或家中)的随机或半随机对照试验。

数据收集与分析

两位综述作者独立评估试验是否纳入,提取数据,并评估纳入研究的偏倚风险。检查数据的准确性。

主要结果

本综述更新纳入了23项涉及8615名女性及其婴儿的试验。10项试验评估了静脉滴注缩宫素;12项试验评估了前列腺素(6项试验采用阴道前列腺素E2形式,6项试验采用口服、舌下含服或阴道米索前列醇);1项试验分别评估了蓝升麻和针灸。总体而言,3项试验被判定为低偏倚风险,而其他20项试验为不明确或高偏倚风险。

主要结局

与足月胎膜早破后接受期待治疗的女性相比,计划早期分娩的女性发生孕产妇感染性疾病(绒毛膜羊膜炎和/或子宫内膜炎)的风险降低(平均风险比(RR)0.49;95%置信区间(CI)0.33至0.72;8项试验,6864名女性;Tau² = 0.19;I² = 72%;低质量证据),其新生儿发生明确或可能的早发型新生儿败血症的可能性较小(RR 0.73;95% CI 0.58至0.92;16项试验,7314名婴儿;低质量证据)。计划早期分娩组与期待治疗组在剖宫产风险方面无明显差异(平均RR 0.84;95% CI 0.69至1.04;23项试验,8576名女性;Tau² = 0.10;I² = 55%;低质量证据);严重孕产妇发病或死亡(无事件;3项试验;425名女性;极低质量证据);明确的早发型新生儿败血症(RR 0.57;95% CI 0.24至1.33;6项试验,1303名婴儿;极低质量证据);或围产期死亡率(RR 0.47;95% CI 0.13至1.66;8项试验,6392名婴儿;中等质量证据)。

次要结局

计划早期分娩的女性发生绒毛膜羊膜炎(平均RR 0.55;95% CI 0.37至0.82;8项试验,6874名女性;Tau² = 0.19;I² = 73%)和产后败血症(RR 0.26;95% CI 0.07至0.96;3项试验,263名女性)的风险降低,其新生儿接受抗生素治疗的可能性较小(平均RR 0.61;95% CI 从0.44至0.84;10项试验,6427名婴儿;Tau² = 0.06;I² = 32%)。计划早期分娩组的女性更有可能接受引产(平均RR 3.41;95% CI 2.87至4.06;12项试验,6945名女性;Tau² = 0.05;I² = 71%),从胎膜破裂到分娩的时间较短(平均差(MD)-10.10小时;95% CI -12.15至-8.06;9项试验,1484名女性;Tau² = 5.81;I² = 算60%),其新生儿出生体重较低(MD -79.25 g;95% CI -124.96至-33.55;5项试验,1043名婴儿)。计划早期分娩的女性住院时间较短(MD -0.79天;95% CI -1.20至-0.38;2项试验,748名女性;Tau² = 0.05;I² = 59%),其新生儿入住新生儿专科或重症监护病房的可能性较小(RR 0.75;95% CI 0.66至0.85;8项试验,6179名婴儿),在医院或专科或重症监护病房的住院时间较短(-11.00小时;95% CI -21.96至-0.04;1项试验,182名婴儿)或住院时间较短(RR 0.72;95% CI 0.61至0.85;4项试验,5691名婴儿)。与期待治疗组的女性相比,计划早期分娩组的女性有更积极的体验。

两组在子宫内膜炎、产后发热、产后抗生素使用、胎儿窘迫剖宫产、阴道助产、子宫破裂、硬膜外镇痛、产后出血、不良反应、脐带脱垂、死产、新生儿死亡、肺炎、5分钟时Apgar评分低于7分、机械通气使用或脑超声异常方面未观察到明显差异(无事件)。

没有试验报告母乳喂养、产后抑郁、出生孕周、脑膜炎、呼吸窘迫综合征、坏死性小肠结肠炎、新生儿脑病或儿童期随访时的残疾情况。

在亚组分析中,对于引产方法、产次、产妇抗生素预防使用或阴道指检,没有明显的差异效应模式。基于试验质量的敏感性分析结果与主要分析结果一致,但在明确或可能的早发型新生儿败血症方面未观察到明显差异。

作者结论

有低质量证据表明,与37周及以后胎膜早破的期待治疗相比,计划早期分娩(采用缩宫素或前列腺素等引产方法)可降低孕产妇感染性疾病的风险,且剖宫产风险无明显增加。证据主要因提供数据的大多数研究存在一些严重的设计局限性而降级,并且对于大多数结局的估计不准确。

尽管本综述纳入的23项试验涉及大量女性和婴儿,但试验和证据的总体质量不高,并且对于一些重要结局的报告有限。因此,进一步评估计划早期分娩与期待治疗相比的益处或危害,考虑孕产妇、胎儿、新生儿和儿童期长期结局以及卫生服务的使用情况,将是有价值的。未来的任何试验都应进行充分设计并具备足够的效力,以评估对短期和长期结局的影响。结局及其定义的标准化,包括对孕产妇和新生儿感染的评估,将是有益的。

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