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一项探索在紧急剖宫产中处理胎头难产方法的随机试验的可接受性和可行性:一项定性研究。

The acceptability and feasibility of a randomised trial exploring approaches to managing impacted fetal head during emergency caesarean section: a qualitative study.

机构信息

Centre for Maternal and Child Health Research, School of Health Sciences, City, University of London, Northampton Square, London, EC1V 0HB, UK.

Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.

出版信息

BMC Pregnancy Childbirth. 2023 Mar 29;23(1):216. doi: 10.1186/s12884-023-05444-5.

Abstract

BACKGROUND

Caesarean sections (CS) account for 26% of all births in the UK, of which at least 5% are done at full dilatation, in the second stage of labour. Second stage CS may be complicated by the fetal head being deeply impacted in the maternal pelvis, requiring specialist skills to achieve a safe birth. Numerous techniques are used to manage impacted fetal head, however, there are no national clinical guidelines in the UK.

AIM

To explore health professionals' and women's views on the acceptability and feasibility of a randomised controlled trial (RCT) designed to explore approaches to managing an impacted fetal head during emergency CS.

METHODS

Semi-structured interviews with 10 obstetricians and 16 women (6 pregnant and 10 who experienced an emergency second stage CS). Interviews were transcribed and analysed using systematic thematic analysis.

RESULTS

The findings considered the time at which you obtain consent, how and when information about the RCT is presented, and barriers and facilitators to recruiting health professionals and women into the RCT. Obstetricians emphasised the importance of training in the techniques, as well as the potential conflict between the RCT protocol and current site or individual practices. Women said they would trust health professionals' to use the most appropriate technique and abandon the RCT protocol if necessary. Similarly, obstetricians raised the tension between the RCT protocol versus safety in reverting to what they knew under emergency situations. Both groups reflected on how this might affect the authenticity of the results. A range of important maternal, infant and clinical outcomes were raised by women and obstetricians. However, there were varying views on which of the two RCT designs presented to participants would be preferred. Most participants thought the RCT would be feasible and acceptable.

CONCLUSIONS

This study suggests an RCT designed to evaluate different techniques for managing an impacted fetal head would be feasible and acceptable. However, it also identified a number of challenges that need to be considered when designing such an RCT. Results can be used to inform the design of RCTs in this area.

摘要

背景

在英国,剖宫产占所有分娩的 26%,其中至少有 5%是在第二产程完全扩张时进行的。第二产程剖宫产可能会因胎儿头部深深地嵌顿在产妇骨盆中而变得复杂,需要专业技能才能实现安全分娩。有许多技术可用于处理嵌顿的胎头,但英国没有国家临床指南。

目的

探讨卫生专业人员和妇女对一项旨在探讨在紧急剖宫产时处理胎头嵌顿方法的随机对照试验(RCT)的可接受性和可行性的看法。

方法

对 10 名产科医生和 16 名妇女(6 名孕妇和 10 名经历紧急第二产程剖宫产的妇女)进行半结构化访谈。对访谈进行转录和系统主题分析。

结果

研究结果考虑了获得同意的时间、如何以及何时介绍 RCT 信息,以及招募卫生专业人员和妇女参加 RCT 的障碍和促进因素。产科医生强调了在技术方面进行培训的重要性,以及 RCT 方案与当前现场或个人实践之间可能存在的冲突。妇女表示,她们会信任卫生专业人员使用最合适的技术,并在必要时放弃 RCT 方案。同样,产科医生提出了 RCT 方案与在紧急情况下恢复他们所知道的安全措施之间的紧张关系。两组人员都考虑了这可能如何影响结果的真实性。妇女和产科医生提出了一系列重要的母婴和临床结果。然而,对于向参与者展示的两种 RCT 设计中的哪一种更受欢迎,存在不同的看法。大多数参与者认为 RCT 是可行和可接受的。

结论

本研究表明,一项旨在评估处理胎头嵌顿的不同技术的 RCT 是可行和可接受的。然而,它也确定了在设计此类 RCT 时需要考虑的一些挑战。研究结果可用于为该领域的 RCT 设计提供信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f2b/10052859/38b784665e92/12884_2023_5444_Fig1_HTML.jpg

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