French L
Department of Family Practice, College of Human Medicine, Michigan State University, B101 Clinical Center, East Lansing, MI 48824, USA.
Cochrane Database Syst Rev. 2001;2001(2):CD003098. doi: 10.1002/14651858.CD003098.
This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
To determine the effects of oral prostaglandin E2 for third trimester induction of labour.
The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Date of last search: December 2000.
The criteria for inclusion included the following: (1) clinical trials comparing oral prostaglandin E2 used 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 allocation to the treatment or control group; (3) 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.
A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. The initial data extraction is done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data will then be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. 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.
There were 19 studies included in the review. Of these 15 included a comparison using either oral or intravenous oxytocin with or without amniotomy. The quality of studies reviewed was not high. Only seven studies had clearly described allocation concealment. Only two studies stated that providers and/or participants were blinded to treatment group. For the outcome of vaginal delivery not achieved within 24 hours, in the composite comparison of oral PGE2 versus all oxytocin treatments (oral and intravenous, with and without amniotomy), there was a trend favoring oxytocin treatments (relative risk (RR) 1.97, 95% confidence interval (CI) 0.86 to 4.48). For the outcome of cesarean section, in the comparison of PGE2 versus no treatment or placebo, PGE2 was favored (relative risk (RR) 0.54, 95% confidence interval (CI) 0.29,0.98). Otherwise, there were no significant differences between groups for this outcome. Oral prostaglandin was associated with vomiting across all comparison groups.
REVIEWER'S CONCLUSIONS: Oral prostaglandin consistently resulted in more frequent gastrointestinal side effects, in particular vomiting, compared with the other treatments included in this review. There were no clear advantages to oral prostaglandin over other methods of induction of labour.
这是一系列使用标准化方法对宫颈成熟和引产方法进行综述中的一篇。
确定口服前列腺素E2用于孕晚期引产的效果。
Cochrane妊娠与分娩组试验注册库、Cochrane对照试验注册库以及相关论文的参考文献。末次检索日期:2000年12月。
纳入标准如下:(1)临床试验,将用于孕晚期宫颈成熟或引产的口服前列腺素E2与安慰剂/未治疗或在预定义引产方法列表中位于其上方的其他方法进行比较;(2)随机分配至治疗组或对照组;(3)充分的分配隐藏;(4)违反分配管理但不足以实质性影响结论;(5)报告有临床意义的结局指标;(6)可根据随机分配进行分析的数据;(7)缺失数据不足以实质性影响结论。
已制定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,并按照标准化方法纳入一系列按引产方法排列的主要综述中。然后将数据从主要综述中提取到一系列按女性类别排列的次要综述中。为避免在主要综述中重复数据,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。
本综述纳入了19项研究。其中15项包括使用口服或静脉缩宫素并伴有或不伴有人工破膜的比较。所综述研究的质量不高。只有7项研究清楚地描述了分配隐藏。只有2项研究表明提供者和/或参与者对治疗组不知情。对于24小时内未实现阴道分娩的结局,在口服PGE2与所有缩宫素治疗(口服和静脉,伴有和不伴有人工破膜)的综合比较中,有缩宫素治疗更占优势的趋势(相对危险度(RR)1.97,95%置信区间(CI)0.86至4.48)。对于剖宫产结局,在PGE2与未治疗或安慰剂的比较中,PGE2更占优势(相对危险度(RR)0.54,95%置信区间(CI)0.29,0.98)。否则,该结局在组间无显著差异。在所有比较组中,口服前列腺素均与呕吐相关。
与本综述中纳入的其他治疗方法相比,口服前列腺素始终导致更频繁的胃肠道副作用,尤其是呕吐。与其他引产方法相比,口服前列腺素没有明显优势。