Kobayashi Shinobu, Hanada Nobutsugu, Matsuzaki Masayo, Takehara Kenji, Ota Erika, Sasaki Hatoko, Nagata Chie, Mori Rintaro
Department of Health Policy, National Center for Child Health and Development, 10-1, Okura 2 chome, Tokyo, Tokyo, Japan, 157-8535.
Department of Midwifery and Women's Health, The University of Tokyo, 7-3-1 Hongo, Tokyo, Japan, 113-0033.
Cochrane Database Syst Rev. 2017 Apr 20;4(4):CD011516. doi: 10.1002/14651858.CD011516.pub2.
The progress of labour in the early or latent phase is usually slow and may include painful uterine contractions. Women may feel distressed and lose their confidence during this phase. Support and assessment interventions have been assessed in two previous Cochrane Reviews. This review updates and replaces these two reviews, which have become out of date.
To investigate the effectiveness of assessment and support interventions for women during early labour.In order to measure the effectiveness of the interventions, we compared the duration of labour, the rate of obstetrical interventions, and the rate of other maternal or neonatal outcomes.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 October 2016) and reference lists of retrieved studies.
Randomised controlled trials of any assessment or support intervention in the latent phase of labour. We planned to include cluster-randomised trials if they were eligible. We did not include quasi-randomised trials.
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We resolved any disagreement by discussion or by involving a third assessor. The quality of the evidence was assessed using the GRADE approach.
We included five trials with a total of 10,421 pregnant women in this review update. The trials were conducted in the UK, Canada and America. The trials compared interventions in early labour versus usual care. We examined three comparisons: early labour assessment versus immediate admission to hospital; home visits by midwives versus usual care (telephone triage); and one-to-one structured midwifery care versus usual care. These trials were at moderate- risk of bias mainly because blinding women and staff to these interventions is not generally feasible. For important outcomes we assessed evidence using GRADE; we downgraded evidence for study design limitations, imprecision, and where we carried out meta-analysis, for inconsistency.One trial with 209 women compared early labour assessment with direct admission to hospital. Duration of labour from the point of hospital admission was reduced for women in the assessment group (mean difference (MD) -5.20 hours, 95% confidence interval (CI) -7.06 to -3.34; 209 women, low-quality evidence). There were no clear differences between groups for the number of women undergoing caesarean section or instrumental vaginal birth (risk ratio (RR) 0.72, 95% CI 0.30 to 1.72, very low quality evidence; and, RR 0.86, 95% CI 0.58 to 1.26, very low quality evidence, respectively). Serious maternal morbidity was not reported. Women in the early assessment group were slightly less likely to have epidural anaesthesia (RR 0.87, 95% CI 0.78 to 0.98, low-quality evidence), and considerably less likely to have oxytocin for labour augmentation (RR 0.57, 95% CI 0.37 to 0.86) and this group also had increased satisfaction with their care compared with women in the immediate admission group (MD 16.00, 95% CI 7.53 to 24.47). No babies were born before admission to hospital and only one infant had a low Apgar score at five minutes after the birth (very low quality evidence). Admission to neonatal special care was not reported.Three studies examined home assessment and midwifery support versus telephone triage. One trial reported the duration of labour; home visits did not appear to have any clear impact compared with usual care (MD 0.29 hours, 95% CI -0.14 to 0.72; 1 trial, 3474 women, low-quality evidence). There was no clear difference for the rate of caesarean section (RR 1.05, 95% CI 0.95 to 1.17; 3 trials, 5170 women; I² = 0%; moderate-quality evidence) or the rate of instrumental vaginal birth (average RR 0.95, 95% CI 0.79 to 1.15; 2 trials, 4933 women; I² = 69%; low-quality evidence). One trial reported birth before arrival at hospital or unplanned home birth; there was no clear difference between the groups (RR 1.33, 95% CI 0.30 to 5.95; 1 trial, 3474 women). No clear differences were identified for serious maternal morbidity (RR 0.93, 95% CI 0.61 to 1.42; 1 trial, 3474 women; low-quality evidence), or use of epidural (average RR 0.95, 95% CI 0.87 to 1.05; 3 trials, 5168 women; I² = 60%; low-quality evidence). There were no clear differences for neonatal admission to special care (average RR 0.84, 95% CI 0.50 to 1.42; 3 trials, 5170 infants; I² = 71%; very low quality evidence), or for Apgar score less than seven at five minutes after birth (RR 1.19, 95% CI 0.71 to 1.99; 3 trials, 5170 infants; I² = 0%; low-quality evidence).One study, with 5002 women, examined one-to-one structured care in early labour versus usual care. Length of labour was not reported. There were no clear differences between groups for the rate of caesarean section (RR 0.93, 95% CI 0.84 to 1.02; 4996 women, high-quality evidence), or for instrumental vaginal birth (RR 0.94, 95% CI 0.82 to 1.08; 4996 women, high-quality evidence). No clear differences between groups were reported for serious maternal morbidity (RR 1.13, 95% CI 0.84 to 1.52; 4996 women, moderate-quality evidence). Use of epidural was similar in the two groups (RR 1.00, 95% CI 0.99 to 1.01; 4996 women, high-quality evidence). For infant outcomes, there were no clear differences between groups (admission to neonatal intensive care unit: RR 0.98, 95% CI 0.80 to 1.21; 4989 infants, high-quality evidence; Apgar score less than seven at five minutes: RR 1.07, 95% CI 0.64 to 1.79; 4989 infants, moderate-quality evidence).
AUTHORS' CONCLUSIONS: Assessment and support in early labour does not have a clear impact on rate of caesarean section or instrumental vaginal birth, or whether the baby was born before arrival at hospital or in an unplanned home birth. However, evidence suggested that interventions may have an impact on reducing the use of epidural anaesthesia, labour augmentation and on increasing maternal satisfaction with giving birth. Evidence about the effectiveness of early labour assessment versus immediate admission was very limited and more research is needed in this area.
分娩早期或潜伏期的产程通常进展缓慢,可能伴有子宫疼痛性收缩。在此阶段,女性可能会感到苦恼并丧失信心。此前两项Cochrane系统评价已对支持与评估干预措施进行了评估。本系统评价对这两项已过时的系统评价进行更新和替换。
探讨分娩早期针对女性的评估与支持干预措施的有效性。为衡量干预措施的有效性,我们比较了产程时长、产科干预率以及其他孕产妇或新生儿结局的发生率。
我们检索了Cochrane妊娠与分娩组试验注册库、ClinicalTrials.gov、世界卫生组织(WHO)国际临床试验注册平台(ICTRP)(2016年10月31日)以及检索到的研究的参考文献列表。
分娩潜伏期任何评估或支持干预措施的随机对照试验。若符合条件,我们计划纳入整群随机试验。我们未纳入半随机试验。
两位综述作者独立评估试验是否纳入及偏倚风险,提取数据并检查其准确性。我们通过讨论或引入第三位评估者解决任何分歧。采用GRADE方法评估证据质量。
在本综述更新中,我们纳入了5项试验,共10421名孕妇。这些试验在英国、加拿大和美国进行。试验比较了分娩早期干预措施与常规护理。我们审查了三项比较:分娩早期评估与直接入院;助产士家访与常规护理(电话分诊);一对一结构化助产护理与常规护理。这些试验存在中度偏倚风险,主要是因为对女性和工作人员隐瞒这些干预措施通常不可行。对于重要结局,我们使用GRADE评估证据;我们因研究设计局限性、不精确性以及在进行Meta分析时存在不一致性而对证据进行了降级。一项纳入209名女性的试验比较了分娩早期评估与直接入院。评估组女性从入院起的产程时长缩短(平均差(MD)-5.20小时,95%置信区间(CI)-7.06至-3.34;209名女性,低质量证据)。两组在剖宫产或器械助产阴道分娩的女性数量上无明显差异(风险比(RR)0.72,95%CI 0.30至1.72,极低质量证据;以及RR 0.86,95%CI 0.58至1.26,极低质量证据)。未报告严重孕产妇发病率。早期评估组的女性接受硬膜外麻醉的可能性略低(RR 0.87,95%CI 0.78至0.98,低质量证据),使用缩宫素加强宫缩的可能性显著降低(RR 0.57,95%CI 0.37至0.86),与直接入院组的女性相比,该组对护理的满意度也有所提高(MD 16.00,95%CI 7.53至24.47)。入院前无婴儿出生,出生后仅一名婴儿5分钟时阿氏评分低(极低质量证据)。未报告新生儿转入特殊护理情况。三项研究考察了家庭评估和助产支持与电话分诊的比较。一项试验报告了产程时长;与常规护理相比,家访似乎没有任何明显影响(MD 0.29小时,95%CI -0.14至0.72;1项试验,3474名女性,低质量证据)。剖宫产率无明显差异(RR 1.05,95%CI 0.95至1.17;3项试验,5170名女性;I² = 0%;中等质量证据)或器械助产阴道分娩率(平均RR 0.95,95%CI 0.79至1.15;2项试验,4933名女性;I² = 69%;低质量证据)。一项试验报告了入院前分娩或计划外在家分娩情况;两组之间无明显差异(RR 1.33,95%CI 0.30至5.95;1项试验,3474名女性)。在严重孕产妇发病率(RR 0.93,95%CI 0.61至1.42;1项试验,3474名女性;低质量证据)或硬膜外麻醉使用情况(平均RR 0.95,95%CI 0.87至1.05;3项试验,5168名女性;I² = 60%;低质量证据)方面未发现明显差异。在新生儿转入特殊护理情况(平均RR 0.84,95%CI 0.50至1.42;3项试验,5170名婴儿;I² = 71%;极低质量证据)或出生后5分钟阿氏评分低于7分(RR 1.19,95%CI 0.71至1.99;3项试验,5170名婴儿;I² = 0%;低质量证据)方面未发现明显差异。一项纳入5002名女性的研究考察了分娩早期一对一结构化护理与常规护理的比较。未报告产程长度。两组在剖宫产率(RR 0.93,95%CI 0.84至1.02;4996名女性,高质量证据)或器械助产阴道分娩率(RR 0.94,95%CI 0.82至1.08;4996名女性,高质量证据)方面无明显差异。两组在严重孕产妇发病率方面未报告明显差异(RR 1.13,95%CI 0.84至1.52;4996名女性,中等质量证据)。两组硬膜外麻醉的使用情况相似(RR 1.00,95%CI 0.99至1.01;4996名女性,高质量证据)。对于婴儿结局,两组之间无明显差异(转入新生儿重症监护病房:RR 0.98,95%CI 0.80至1.21;4989名婴儿,高质量证据;出生后5分钟阿氏评分低于7分:RR 1.07,95%CI 0.64至1.79;4989名婴儿,中等质量证据)。
分娩早期的评估与支持对剖宫产率或器械助产阴道分娩率,或婴儿是否在入院前出生或计划外在家分娩没有明显影响。然而,有证据表明,干预措施可能对减少硬膜外麻醉的使用、加强宫缩以及提高产妇对分娩的满意度有影响。关于分娩早期评估与直接入院有效性的证据非常有限,该领域需要更多研究。