School of Community Health and Midwifery, University of Central Lancashire, Preston, UK.
Cochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD010088. doi: 10.1002/14651858.CD010088.pub3.
Routine vaginal examinations are undertaken at regular time intervals during labour to assess whether labour is progressing as expected. Unusually slow progress can be due to underlying problems, described as labour dystocia, or can be a normal variation of progress. Evidence suggests that if mother and baby are well, length of labour alone should not be used to decide whether labour is progressing normally. Other methods to assess labour progress include intrapartum ultrasound and monitoring external physical and behavioural cues. Vaginal examinations can be distressing for women, and overdiagnosis of dystocia can result in iatrogenic morbidity due to unnecessary intervention. It is important to establish whether routine vaginal examinations are effective, both as an accurate measure of physiological labour progress and to distinguish true labour dystocia, or whether other methods for assessing labour progress are more effective. This Cochrane Review is an update of a review first published in 2013.
To compare the effectiveness, acceptability, and consequences of routine vaginal examinations compared with other methods, or different timings, to assess labour progress at term.
For this update, we searched Cochrane Pregnancy and Childbirth Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, and conference proceedings) and ClinicalTrials.gov (28 February 2021). We also searched the reference lists of retrieved studies.
We included randomised controlled trials (RCTs) of vaginal examinations compared with other methods of assessing labour progress and studies assessing different timings of vaginal examinations. Quasi-RCTs and cluster-RCTs were eligible for inclusion. We excluded cross-over trials and conference abstracts.
Two review authors independently assessed all studies identified by the search for inclusion in the review. Four review authors independently extracted data. Two review authors assessed risk of bias and certainty of the evidence using GRADE.
We included four studies that randomised a total of 755 women, with data analysed for 744 women and their babies. Interventions used to assess labour progress were routine vaginal examinations, routine ultrasound assessments, routine rectal examinations, routine vaginal examinations at different frequencies, and vaginal examinations as indicated. We were unable to conduct meta-analysis as there was only one study for each comparison. All studies were at high risk of performance bias due to difficulties with blinding. We assessed two studies as high risk of bias and two as low or unclear risk of bias for other domains. The overall certainty of the evidence assessed using GRADE was low or very low. Routine vaginal examinations versus routine ultrasound to assess labour progress (one study, 83 women and babies) Study in Turkey involving multiparous women with spontaneous onset of labour. Routine vaginal examinations may result in a slight increase in pain compared to routine ultrasound (mean difference -1.29, 95% confidence interval (CI) -2.10 to -0.48; one study, 83 women, low certainty evidence) (pain measured using a visual analogue scale (VAS) in reverse: zero indicating 'worst pain', 10 indicating no pain). The study did not assess our other primary outcomes: positive birth experience; augmentation of labour; spontaneous vaginal birth; chorioamnionitis; neonatal infection; admission to neonatal intensive care unit (NICU). Routine vaginal examinations versus routine rectal examinations to assess labour progress (one study, 307 women and babies) Study in Ireland involving women in labour at term. We assessed the certainty of the evidence as very low. Compared with routine rectal examinations, routine vaginal examinations may have little or no effect on: augmentation of labour (risk ratio (RR) 1.03, 95% CI 0.63 to 1.68; one study, 307 women); and spontaneous vaginal birth (RR 0.98, 95% CI 0.90 to 1.06; one study, 307 women). We found insufficient data to fully assess: neonatal infections (RR 0.33, 95% CI 0.01 to 8.07; one study, 307 babies); and admission to NICU (RR 1.32, 95% CI 0.47 to 3.73; one study, 307 babies). The study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; maternal pain. Routine four-hourly vaginal examinations versus routine two-hourly examinations (one study, 150 women and babies) UK study involving primiparous women in labour at term. We assessed the certainty of the evidence as very low. Compared with routine two-hourly vaginal examinations, routine four-hourly vaginal examinations may have little or no effect, with data compatible with both benefit and harm, on: augmentation of labour (RR 0.97, 95% CI 0.60 to 1.57; one study, 109 women); and spontaneous vaginal birth (RR 1.02, 95% CI 0.83 to 1.26; one study, 150 women). The study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; neonatal infection; admission to NICU; maternal pain. Routine vaginal examinations versus vaginal examinations as indicated (one study, 204 women and babies) Study in Malaysia involving primiparous women being induced at term. We assessed the certainty of the evidence as low. Compared with vaginal examinations as indicated, routine four-hourly vaginal examinations may result in more women having their labour augmented (RR 2.55, 95% CI 1.03 to 6.31; one study, 204 women). There may be little or no effect on: • spontaneous vaginal birth (RR 1.08, 95% CI 0.73 to 1.59; one study, 204 women); • chorioamnionitis (RR 3.06, 95% CI 0.13 to 74.21; one study, 204 women); • neonatal infection (RR 4.08, 95% CI 0.46 to 35.87; one study, 204 babies); • admission to NICU (RR 2.04, 95% CI 0.63 to 6.56; one study, 204 babies). The study did not assess our other primary outcomes of positive birth experience or maternal pain.
AUTHORS' CONCLUSIONS: Based on these findings, we cannot be certain which method is most effective or acceptable for assessing labour progress. Further large-scale RCT trials are required. These should include essential clinical and experiential outcomes. This may be facilitated through the development of a tool to measure positive birth experiences. Data from qualitative studies are also needed to fully assess whether methods to evaluate labour progress meet women's needs for a safe and positive labour and birth, and if not, to develop an approach that does.
在分娩过程中，常规阴道检查是定期进行的，以评估分娩是否按预期进行。进展异常缓慢可能是由于潜在问题，即产程困难，也可能是进展的正常变化。有证据表明，如果母亲和婴儿状况良好，仅分娩时间不应作为判断分娩是否正常的依据。评估分娩进展的其他方法包括产程中超声检查和监测外部生理和行为线索。阴道检查可能会给女性带来不适，过度诊断产程困难会导致不必要的干预带来医源性发病率。重要的是要确定常规阴道检查是否有效，既是生理分娩进展的准确衡量标准，也是区分真正的产程困难，还是其他评估分娩进展的方法更有效。本 Cochrane 综述是对首次发表于 2013 年的综述的更新。
比较常规阴道检查与其他方法（或不同时间间隔）在评估足月分娩进展方面的有效性、可接受性和后果。
为本次更新，我们检索了 Cochrane 妊娠和分娩试验注册库（包括来自 CENTRAL、MEDLINE、Embase、CINAHL 和会议论文集的试验）和 ClinicalTrials.gov（2021 年 2 月 28 日）。我们还检索了已检索研究的参考文献列表。
我们纳入了比较阴道检查与评估分娩进展的其他方法的随机对照试验（RCT）和评估阴道检查不同时间间隔的研究。合格的包括准随机对照试验和整群随机对照试验。我们排除了交叉试验和会议摘要。
两位综述作者独立评估了搜索结果中符合纳入标准的所有研究。四位综述作者独立提取数据。两位综述作者使用 GRADE 评估了风险偏倚和证据的确定性。
我们纳入了四项研究，共纳入了 755 名女性，其中 744 名女性及其婴儿的数据进行了分析。用于评估分娩进展的干预措施包括常规阴道检查、常规超声评估、常规直肠检查、不同频率的常规阴道检查和按需进行的阴道检查。由于难以进行盲法，我们无法进行荟萃分析。每项比较只有一项研究。所有研究均存在高度偏倚风险，因为难以进行盲法。我们将两项研究评估为高偏倚风险，将两项研究评估为其他领域的高偏倚风险或低偏倚风险或不明确偏倚风险。使用 GRADE 评估的证据总体确定性为低或非常低。
常规阴道检查与常规超声检查评估分娩进展（一项研究，83 名妇女和婴儿）：土耳其的一项研究涉及有自发分娩的多产妇。与常规超声检查相比，常规阴道检查可能会导致疼痛略有增加（平均差异-1.29，95%置信区间（CI）-2.10 至-0.48；一项研究，83 名妇女，低确定性证据）（疼痛使用反向视觉模拟量表（VAS）测量：零表示“最痛”，10 表示无痛）。该研究未评估我们的其他主要结局：积极的分娩体验；产程延长；自然阴道分娩；绒毛膜羊膜炎；新生儿感染；入住新生儿重症监护病房（NICU）。
常规阴道检查与常规直肠检查评估分娩进展（一项研究，307 名妇女和婴儿）：爱尔兰的一项研究涉及足月分娩的妇女。我们将证据的确定性评估为非常低。与常规直肠检查相比，常规阴道检查可能对以下方面几乎没有或没有影响：产程延长（风险比（RR）1.03，95%置信区间（CI）0.63 至 1.68；一项研究，307 名妇女）；和自然阴道分娩（RR 0.98，95%置信区间（CI）0.90 至 1.06；一项研究，307 名妇女）。我们发现数据不足以充分评估：新生儿感染（RR 0.33，95%置信区间（CI）0.01 至 8.07；一项研究，307 名婴儿）；和入住 NICU（RR 1.32，95%置信区间（CI）0.47 至 3.73；一项研究，307 名婴儿）。该研究未评估我们的其他主要结局：积极的分娩体验；绒毛膜羊膜炎；产妇疼痛。
常规四小时一次阴道检查与常规两小时一次阴道检查评估分娩进展（一项研究，150 名妇女和婴儿）：英国的一项研究涉及足月分娩的初产妇。我们将证据的确定性评估为非常低。与常规两小时一次阴道检查相比，常规四小时一次阴道检查可能几乎没有或没有效果，数据既支持获益，也支持危害，对以下方面几乎没有或没有影响：产程延长（RR 0.97，95%置信区间（CI）0.60 至 1.57；一项研究，109 名妇女）；和自然阴道分娩（RR 1.02，95%置信区间（CI）0.83 至 1.26；一项研究，150 名妇女）。该研究未评估我们的其他主要结局：积极的分娩体验；绒毛膜羊膜炎；新生儿感染；入住 NICU；产妇疼痛。
常规阴道检查与按需进行的阴道检查评估分娩进展（一项研究，204 名妇女和婴儿）：马来西亚的一项研究涉及接受诱导分娩的初产妇。我们将证据的确定性评估为低。与按需进行的阴道检查相比，常规四小时一次阴道检查可能会导致更多的妇女需要进行产程延长（RR 2.55，95%置信区间（CI）1.03 至 6.31；一项研究，204 名妇女）。可能对以下方面几乎没有或没有影响：
自然阴道分娩（RR 1.08，95%置信区间（CI）0.73 至 1.59；一项研究，204 名妇女）；
绒毛膜羊膜炎（RR 3.06，95%置信区间（CI）0.13 至 74.21；一项研究，204 名妇女）；
新生儿感染（RR 4.08，95%置信区间（CI）0.46 至 35.87；一项研究，204 名婴儿）；
入住 NICU（RR 2.04，95%置信区间（CI）0.63 至 6.56；一项研究，204 名婴儿）。该研究未评估我们的其他主要结局：积极的分娩体验或产妇疼痛。
基于这些发现，我们不能确定哪种方法在评估分娩进展方面最有效或最可接受。需要进一步进行大规模的 RCT 试验。这些试验应包括基本的临床和体验结局。这可能通过开发一种衡量积极分娩体验的工具来促进。还需要定性研究的数据，以充分评估评估分娩进展的方法是否满足妇女对安全和积极分娩的需求，如果没有，则开发一种满足该需求的方法。
