Vogel Joshua P, Osoti Alfred O, Kelly Anthony J, Livio Stefania, Norman Jane E, Alfirevic Zarko
UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland, CH-1211.
Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701. doi: 10.1002/14651858.CD007701.pub3.
Induction of labour is carried out for a variety of indications and using a range of methods. For women at low risk of pregnancy complications, some methods of induction of labour or cervical ripening may be suitable for use in outpatient settings.
To examine pharmacological and mechanical interventions to induce labour or ripen the cervix in outpatient settings in terms of effectiveness, maternal satisfaction, healthcare costs and, where information is available, safety.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016) and reference lists of retrieved studies.
We included randomised controlled trials examining outpatient cervical ripening or induction of labour with pharmacological agents or mechanical methods. Cluster trials were eligible for inclusion.
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed evidence using the GRADE approach.
This updated review included 34 studies of 11 different methods for labour induction with 5003 randomised women, where women received treatment at home or were sent home after initial treatment and monitoring in hospital.Studies examined vaginal and intracervical prostaglandin E₂ (PGE₂), vaginal and oral misoprostol, isosorbide mononitrate, mifepristone, oestrogens, amniotomy and acupuncture, compared with placebo, no treatment, or routine care. Trials generally recruited healthy women with a term pregnancy. The risk of bias was mostly low or unclear, however, in 16 trials blinding was unclear or not attempted. In general, limited data were available on the review's main and additional outcomes. Evidence was graded low to moderate quality. 1. Vaginal PGE₂ versus expectant management or placebo (5 studies)Fewer women in the vaginal PGE₂ group needed additional induction agents to induce labour, however, confidence intervals were wide (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.27 to 0.99; 150 women; 2 trials). There were no clear differences between groups in uterine hyperstimulation (with or without fetal heart rate (FHR) changes) (RR 3.76, 95% CI 0.64 to 22.24; 244 women; 4 studies; low-quality evidence), caesarean section (RR 0.80, 95% CI 0.49 to 1.31; 288 women; 4 studies; low-quality evidence), or admission to a neonatal intensive care unit (NICU) (RR 0.32, 95% CI 0.10 to 1.03; 230 infants; 3 studies; low-quality evidence).There was no information on vaginal birth within 24, 48 or 72 hours, length of hospital stay, use of emergency services or maternal or caregiver satisfaction. Serious maternal and neonatal morbidity or deaths were not reported. 2. Intracervical PGE₂ versus expectant management or placebo (7 studies) There was no clear difference between women receiving intracervical PGE₂ and no treatment or placebo in terms of need for additional induction agents (RR 0.98, 95% CI 0.74 to 1.32; 445 women; 3 studies), vaginal birth not achieved within 48 to 72 hours (RR 0.83, 95% CI 0.68 to 1.02; 43 women; 1 study; low-quality evidence), uterine hyperstimulation (with FHR changes) (RR 2.66, 95% CI 0.63 to 11.25; 488 women; 4 studies; low-quality evidence), caesarean section (RR 0.90, 95% CI 0.72 to 1.12; 674 women; 7 studies; moderate-quality evidence), or babies admitted to NICU (RR 1.61, 95% CI 0.43 to 6.05; 215 infants; 3 studies; low-quality evidence). There were no uterine ruptures in either the PGE₂ group or placebo group.There was no information on vaginal birth not achieved within 24 hours, length of hospital stay, use of emergency services, mother or caregiver satisfaction, or serious morbidity or neonatal morbidity or perinatal death. 3. Vaginal misoprostol versus placebo (4 studies)One small study reported on the rate of perinatal death with no clear differences between groups; there were no deaths in the treatment group compared with one stillbirth (reason not reported) in the control group (RR 0.34, 95% CI 0.01 to 8.14; 77 infants; 1 study; low-quality evidence).There was no clear difference between groups in rates of uterine hyperstimulation with FHR changes (RR 1.97, 95% CI 0.43 to 9.00; 265 women; 3 studies; low-quality evidence), caesarean section (RR 0.94, 95% CI 0.61 to 1.46; 325 women; 4 studies; low-quality evidence), and babies admitted to NICU (RR 0.89, 95% CI 0.54 to 1.47; 325 infants; 4 studies; low-quality evidence).There was no information on vaginal birth not achieved within 24, 48 or 72 hours, additional induction agents required, length of hospital stay, use of emergency services, mother or caregiver satisfaction, serious maternal, and other neonatal, morbidity or death.No substantive differences were found for other comparisons. One small study found that women who received oral misoprostol were more likely to give birth within 24 hours (RR 0.65, 95% CI 0.48 to 0.86; 87 women; 1 study) and were less likely to require additional induction agents (RR 0.60, 95% CI 0.37 to 0.97; 127 women; 2 studies). Women who received mifepristone were also less likely to require additional induction agents (average RR 0.59, 95% CI 0.37 to 0.95; 311 women; 4 studies; I² = 74%); however, this result should be interpreted with caution due to high heterogeneity. One trial each of acupuncture and outpatient amniotomy were included, but few review outcomes were reported.
AUTHORS' CONCLUSIONS: Induction of labour in outpatient settings appears feasible and important adverse events seem rare, however, in general there is insufficient evidence to detect differences. There was no strong evidence that agents used to induce labour in outpatient settings had an impact (positive or negative) on maternal or neonatal health. There was some evidence that compared to placebo or no treatment, induction agents administered on an outpatient basis reduced the need for further interventions to induce labour, and shortened the interval from intervention to birth.We do not have sufficient evidence to know which induction methods are preferred by women, the interventions that are most effective and safe to use in outpatient settings, or their cost effectiveness. Further studies where various women-friendly outpatient protocols are compared head-to-head are required. As part of such work, women should be consulted on what sort of management they would prefer.
引产因各种指征而进行，采用多种方法。对于妊娠并发症风险低的女性，某些引产或宫颈成熟方法可能适用于门诊环境。
从有效性、产妇满意度、医疗成本以及（若有可用信息）安全性方面，研究门诊环境下引产或使宫颈成熟的药物和机械干预措施。
我们检索了Cochrane妊娠和分娩组试验注册库（2016年11月30日）以及检索到的研究的参考文献列表。
我们纳入了检查门诊宫颈成熟或使用药物或机械方法引产的随机对照试验。整群试验符合纳入条件。
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。我们采用GRADE方法评估证据。
本次更新综述纳入了34项关于11种不同引产方法的研究，共有5003名随机分组的女性，这些女性在家接受治疗或在医院初步治疗和监测后被送回家。研究考察了阴道和宫颈内前列腺素E₂（PGE₂）、阴道和口服米索前列醇、单硝酸异山梨酯、米非司酮、雌激素、人工破膜和针灸，与安慰剂、不治疗或常规护理进行比较。试验通常招募足月妊娠的健康女性。偏倚风险大多为低或不明确，然而，在16项试验中，盲法不明确或未尝试。总体而言，关于综述的主要和其他结局的可用数据有限。证据质量为低到中等。1. 阴道PGE₂与期待管理或安慰剂（5项研究）阴道PGE₂组中需要额外引产剂来引产的女性较少，然而，置信区间较宽（风险比（RR）0.52，95%置信区间（CI）0.27至0.99；150名女性；2项试验）。两组在子宫过度刺激（伴有或不伴有胎儿心率（FHR）变化）方面无明显差异（RR 3.76，95%CI 0.64至22.24；244名女性；4项研究；低质量证据）、剖宫产（RR 0.80，95%CI 0.49至1.31；288名女性；4项研究；低质量证据）或入住新生儿重症监护病房（NICU）（RR 0.32，95%CI 0.10至1.03；230名婴儿；3项研究；低质量证据）。没有关于24、48或72小时内阴道分娩、住院时间、急诊服务使用情况或产妇或护理人员满意度的信息。未报告严重的孕产妇和新生儿发病率或死亡情况。2. 宫颈内PGE₂与期待管理或安慰剂（7项研究）接受宫颈内PGE₂的女性与未治疗或安慰剂组在需要额外引产剂方面无明显差异（RR 0.98，95%CI 0.74至1.32；445名女性；3项研究）、48至72小时内未实现阴道分娩（RR 0.83，95%CI 0.68至1.02；43名女性；1项研究；低质量证据）、子宫过度刺激（伴有FHR变化）（RR 2.66，95%CI 0.63至11.25；488名女性；4项研究；低质量证据）、剖宫产（RR 0.90，95%CI 0.72至1.12；674名女性；7项研究；中等质量证据）或入住NICU的婴儿（RR 1.61，95%CI 0.43至6.05；215名婴儿；3项研究；低质量证据）方面。PGE₂组或安慰剂组均未发生子宫破裂。没有关于24小时内未实现阴道分娩、住院时间、急诊服务使用情况、母亲或护理人员满意度或严重发病率或新生儿发病率或围产期死亡的信息。3. 阴道米索前列醇与安慰剂（4项研究）一项小型研究报告了围产期死亡率，两组之间无明显差异；治疗组无死亡，而对照组有1例死产（原因未报告）（RR 0.34，95%CI 0.01至8.14；77名婴儿；1项研究；低质量证据）。两组在伴有FHR变化的子宫过度刺激率方面无明显差异（RR 1.97，95%CI 0.4至9.00；265名女性；3项研究；低质量证据）、剖宫产（RR 0.94，95%CI 0.61至1.46；325名女性；4项研究；低质量证据）以及入住NICU的婴儿（RR 0.89，95%CI 0.54至1.47；325名婴儿；4项研究；低质量证据）。没有关于24小时、48小时或72小时内未实现阴道分娩、所需额外引产剂、住院时间、急诊服务使用情况、母亲或护理人员满意度、严重孕产妇和其他新生儿发病率或死亡的信息。其他比较未发现实质性差异。一项小型研究发现，接受口服米索前列醇的女性更有可能在24小时内分娩（RR 0.65，95%CI 0.48至0.86；87名女性；1项研究），且需要额外引产剂的可能性较小（RR 0.60，95%CI 0.37至0.97；127名女性；2项研究）。接受米非司酮的女性也较少需要额外引产剂（平均RR 0.59，95%CI 0.37至0.95；311名女性；4项研究；I² = 74%）；然而，由于异质性高，该结果应谨慎解释。针灸和门诊人工破膜各有一项试验纳入，但报告的综述结局较少。
门诊引产似乎可行，严重不良事件似乎罕见，然而，总体而言，检测差异证据不足。没有强有力的证据表明门诊引产所用药物对孕产妇或新生儿健康有影响（正面或负面）。有一些证据表明，与安慰剂或不治疗相比，门诊使用引产剂减少了进一步引产干预的需求，并缩短了从干预到分娩的间隔。我们没有足够的证据了解女性更喜欢哪种引产方法、门诊环境中最有效和安全的干预措施或其成本效益。需要进一步进行各种对女性友好的门诊方案的直接比较研究。作为这项工作的一部分，应就女性更喜欢何种管理方式征求她们的意见。
