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比较用于标准分娩护理的不同产程图设计:一项试点随机试验。

Comparing Different Partograph Designs for Use in Standard Labor Care: A Pilot Randomized Trial.

作者信息

Lee Nigel J, Neal Jeremy, Lowe Nancy K, Kildea Sue V

机构信息

Midwifery Research Unit, School of Nursing, Midwifery and Social Work, The University of Queensland (UQ), Brisbane, QLD, Australia.

Mater Research Institute - UQ, Mater Health Services, Aubigny Place, Raymond Terrace, South Brisbane, QLD, 4101, Australia.

出版信息

Matern Child Health J. 2018 Mar;22(3):355-363. doi: 10.1007/s10995-017-2366-0.

Abstract

Backgound Partographs are used in many labour settings to provide a pictorial overview of a woman's cervical dilation pattern in the first stage of labor and to alert clinicians to slow progress possibly requiring intervention. Recent reviews called for large trials to establish the efficacy of partographs to improve birth outcomes whilst highlighting issues of clinician compliance with use. Previous studies have also reported issues with participant recruitment related to concerns regarding the possibility of a longer labour. Objectives We sought to compare a standard partograph with an action line, to a newly designed partograph with a stepped line, to determine the feasibility of recruitment to a larger clinical trial. Methods A pragmatic, single-blind randomised trial wherein low-risk, nulliparous women in spontaneous labour at term were randomized to an action-line or stepped-line partograph. First stage labour management was guided by the allocated partograph. Primary outcomes included the proportion of eligible women recruited, reasons for failed recruitment and compliance with partograph use. Secondary outcomes included rates of intervention, mode of birth, maternal and neonatal outcomes. Results Of the 384 potentially eligible participants, 38% (149/384) were approached. Of these 77% (116/149) consented, with 85% (99/116) randomized, only nine women approached (6%) declined to participate. A further 9% (14/149) who were consented antenatally were not eligible at onset of labor and 7% (10/149) of women approached in the birth suite but did not meet the inclusion criteria. Compliance with partograph completion was 65% (action) versus 84% (dystocia line). Conclusions for Practice Participant recruitment to a larger randomized controlled trial comparing new labour management guidelines to standard care is feasible. Effective strategies to improve partograph completion compliance would be required to maintain trial fidelity.

摘要

背景 产程图在许多分娩环境中用于直观呈现产妇第一产程宫颈扩张模式,并提醒临床医生注意进展缓慢可能需要干预的情况。近期综述呼吁开展大型试验以确定产程图改善分娩结局的有效性,同时强调临床医生使用产程图的依从性问题。此前研究也报告了与分娩时间可能延长的担忧相关的受试者招募问题。目的 我们试图比较标准行动线产程图与新设计的阶梯线产程图,以确定招募受试者参加更大规模临床试验的可行性。方法 一项实用、单盲随机试验,将足月自然分娩的低风险初产妇随机分配至行动线或阶梯线产程图组。第一产程管理由分配的产程图指导。主要结局包括招募的符合条件女性比例、招募失败原因以及产程图使用的依从性。次要结局包括干预率、分娩方式、母婴结局。结果 在384名潜在符合条件的参与者中,38%(149/384)被邀请参与。其中77%(116/149)同意,85%(99/116)被随机分组,只有9名被邀请的女性(6%)拒绝参与。另外9%(14/149)产前同意的女性在临产时不符合条件,7%(10/149)在产房被邀请但不符合纳入标准。产程图填写的依从性为行动线组65%,难产线组84%。实践结论 招募受试者参加比较新的分娩管理指南与标准护理的更大规模随机对照试验是可行的。需要有效的策略来提高产程图填写的依从性以维持试验的保真度。

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