Bricker L, Luckas M
University Department of Obstetrics and Gynaecology, Liverpool Women's Hospital, Crown Street, Liverpool, UK, L8 7SS.
Cochrane Database Syst Rev. 2000;2000(4):CD002862. doi: 10.1002/14651858.CD002862.
Amniotomy (deliberate rupture of the membranes) is a simple procedure which can be used alone for induction of labour if the membranes are accessible, thus avoiding the need for pharmacological intervention. However, the time interval from amniotomy to established labour may not be acceptable to clinicians and women, and in a number of cases labour may not ensue. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
To determine the effects of amniotomy alone for third trimester labour induction in women with a live fetus.
The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled trials register and bibliographies of relevant papers.
The criteria for inclusion included the following: (1) clinical trials comparing amniotomy alone for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random or pseudo-random allocation to the treatment or control group; (3) ideally adequate allocation concealment (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions.
This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into the series of primary reviews arranged by methods of induction of labour. The data from the primary reviews will be incorporated into a series of secondary reviews, arranged by category of woman to reflect clinical scenarios. To avoid duplication of data in the primary reviews, the labour induction methods have been listed in a specific order, from one to 25. Each primary review includes comparisons between one of the methods (from two to 25) with only those methods above it on the list. This review includes comparisons between amniotomy alone (number 5 on the list) with only those methods above it on the list (no treatment / placebo; intravaginal prostaglandins; intracervical prostaglandins; and oxytocin alone).
Two trials comprising 50 and 260 women respectively were eligible for inclusion in this review. No conclusions could be drawn from comparisons of amniotomy alone versus no intervention, and amniotomy alone versus oxytocin alone (small trial, only one pre-specified outcome reported). No trials compared amniotomy alone with intracervical prostaglandins. One trial compared amniotomy alone with a single dose of vaginal prostaglandins for women with a favourable cervix, and found a significant increase in the need for oxytocin augmentation in the amniotomy alone group (44% versus 15%; RR 2.85, 95% CI 1.82-4.46). This should be viewed with caution as this was the result of a single centre trial. Furthermore, secondary intervention occurred 4 hours after amniotomy, and this time interval may not have been appropriate.
REVIEWER'S CONCLUSIONS: Data is lacking about the value of amniotomy alone for induction of labour. While there are now other modern methods available for induction of labour (pharmacological agents), there remain clinical scenarios where amniotomy alone may be desirable and appropriate, and this method is worthy of further research. This research should include evaluation of the appropriate time interval from amniotomy to secondary intervention, women and caregivers' satisfaction and economic analysis.
人工破膜(故意刺破胎膜)是一种简单的操作,如果胎膜易于触及,可单独用于引产,从而避免药物干预的需要。然而,从人工破膜到正式分娩的时间间隔可能是临床医生和产妇所不能接受的,而且在许多情况下可能不会引发分娩。这是一系列使用标准化方法对宫颈成熟和引产方法进行的综述之一。
确定单独使用人工破膜对有活胎的晚期妊娠妇女引产的效果。
考克兰妊娠与分娩组试验注册库、考克兰对照试验注册库以及相关论文的参考文献。
入选标准如下:(1)临床试验,将单独使用人工破膜进行晚期妊娠宫颈成熟或引产与安慰剂/不治疗或在预定义引产方法列表中列于其上方的其他方法进行比较;(2)随机或准随机分配至治疗组或对照组;(3)理想情况下有充分的分配隐藏;(4)违反分配的管理不足以实质性影响结论;(5)报告有临床意义的结局指标;(6)可根据随机分配获得用于分析的数据;(7)缺失数据不足以实质性影响结论。
这是一系列使用标准化方法对宫颈成熟和引产方法进行的综述之一。制定了一项策略来处理与引产相关的大量且复杂的试验数据。这涉及两阶段的数据提取方法。初始数据提取在中心进行,并纳入按引产方法排列的一系列主要综述中。主要综述的数据将纳入按妇女类别排列的一系列次要综述中,以反映临床情况。为避免主要综述中数据的重复,引产方法已按特定顺序列出,从1到25。每项主要综述包括其中一种方法(从2到25)与列表中仅位于其上方的那些方法之间的比较。本综述包括单独人工破膜(列表中的第5种方法)与列表中仅位于其上方的那些方法(不治疗/安慰剂;阴道前列腺素;宫颈内前列腺素;以及单独使用缩宫素)之间的比较。
两项试验分别纳入了50名和260名妇女,符合本综述的纳入标准。单独人工破膜与不干预以及单独人工破膜与单独使用缩宫素的比较无法得出结论(试验规模小,仅报告了一项预先指定的结局)。没有试验将单独人工破膜与宫颈内前列腺素进行比较。一项试验将单独人工破膜与单剂量阴道前列腺素用于宫颈条件良好的妇女进行了比较,发现单独人工破膜组缩宫素加强引产的需求显著增加(44%对15%;RR 2.85,95%CI 1.82 - 4.46)。由于这是一项单中心试验的结果,应谨慎看待。此外,二次干预在人工破膜后4小时发生,这个时间间隔可能不合适。
缺乏关于单独人工破膜引产价值的数据。虽然现在有其他现代引产方法(药物制剂),但仍有一些临床情况单独人工破膜可能是可取且合适的,这种方法值得进一步研究。该研究应包括评估从人工破膜到二次干预的合适时间间隔、产妇和医护人员的满意度以及经济分析。