Cluett E R, Pickering R M, Brooking J I
School of Nursing and Midwifery, University of Southampton, Highfield, UK.
Midwifery. 2001 Mar;17(1):35-43. doi: 10.1054/midw.2000.0233.
to evaluate the feasibility of a randomised controlled trial (RCT) examining the effect of three options (augmentation, conservative and water) for the management of dystocia in nulliparae. The main objectives were to explore the feasibility of trial procedures in the clinical environment, consent rates and acceptability of the management options to women, local incidence of dystocia in nulliparae and the size of the subsequent study.
a two part study: a pilot, RCT with follow-up through to delivery with postnatal maternal surveys, and a case review of nulliparae with dystocia.
a large maternity unit in the South of England in May-July 1997 inclusive.
nulliparae with dystocia in the first stage of labour who had an otherwise uncomplicated obstetric background.
women in the pilot RCT received one of three management options: labouring in a waterbirth pool, conservative management or augmentation of labour, which is the standard management of women with dystocia condition in the Unit.
it is feasible to conduct an RCT of management of dystocia in the Unit. Seventy per cent (95% confidence interval 47% to 87%) of women approached agreed to participate. Conservative management was the least acceptable option to women and has been dropped from the subsequent trial. The audit provided some idea of possible differences in operative delivery and epidural rates depending on augmentation or not. A sample of 220 women should be large enough to detect moderate changes and will require a 2-year recruitment period.
a subsequent trial is feasible and is now underway. It has the potential to provide information enabling women and practitioners to have a greater choice of care options in the presence of dystocia, or provide a good basis for an even larger trial.
评估一项随机对照试验(RCT)的可行性,该试验旨在研究三种处理初产妇难产的方法(增强宫缩、保守处理和水中分娩)的效果。主要目的是探讨在临床环境中试验程序的可行性、妇女对处理方法的同意率和可接受性、初产妇难产的当地发生率以及后续研究的规模。
一项分为两部分的研究:一项试点随机对照试验,随访至分娩并进行产后产妇调查,以及对难产初产妇的病例回顾。
1997年5月至7月(含)期间英格兰南部的一家大型产科单位。
处于第一产程难产的初产妇,其产科背景无其他并发症。
试点随机对照试验中的妇女接受三种处理方法之一:在水中分娩池分娩、保守处理或增强宫缩,增强宫缩是该单位处理难产妇女的标准方法。
在该单位进行难产处理的随机对照试验是可行的。被邀请的妇女中有70%(95%置信区间47%至87%)同意参与。保守处理是妇女最不可接受的选择,已从后续试验中剔除。审计提供了一些关于根据是否增强宫缩,手术分娩率和硬膜外麻醉率可能存在差异的信息。220名妇女的样本量应足以检测出中等程度的变化,且招募期需要2年。
后续试验是可行的,目前正在进行。它有可能提供信息,使妇女和从业者在难产时能有更多的护理选择,或者为更大规模的试验提供良好基础。