Begley Cecily M, Gyte Gillian Ml, Devane Declan, McGuire William, Weeks Andrew, Biesty Linda M
School of Nursing and Midwifery, Trinity College Dublin, 24 D'Olier Street, Dublin, Ireland.
Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD007412. doi: 10.1002/14651858.CD007412.pub5.
Active management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries. This is an update of a review last published in 2015.
To compare the effects of active versus expectant management of the third stage of labour on severe primary postpartum haemorrhage (PPH) and other maternal and infant outcomes.To compare the effects of variations in the packages of active and expectant management of the third stage of labour on severe primary PPH and other maternal and infant outcomes.
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World health Organization International Clinical Trials Registry Platform (ICTRP), on 22 January 2018, and reference lists of retrieved studies.
Randomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour. Cluster-randomised trials were eligible for inclusion, but none were identified.
Two review authors independently assessed the studies for inclusion, assessed risk of bias, carried out data extraction and assessed the quality of the evidence using the GRADE approach.
We included eight studies, involving analysis of data from 8892 women. The studies were all undertaken in hospitals, seven in higher-income countries and one in a lower-income country. Four studies compared active versus expectant management, and four compared active versus a mixture of managements. We used a random-effects model in the analyses because of clinical heterogeneity. Of the eight studies included, we considered three studies as having low risk of bias in the main aspects of sequence generation, allocation concealment and completeness of data collection. There was an absence of high-quality evidence according to GRADE assessments for our primary outcomes, which is reflected in the cautious language below.The evidence suggested that, for women at mixed levels of risk of bleeding, it is uncertain whether active management reduces the average risk of maternal severe primary PPH (more than 1000 mL) at time of birth (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, 3 studies, 4636 women, I = 60%; GRADE: very low quality). For incidence of maternal haemoglobin (Hb) less than 9 g/dL following birth, active management of the third stage may reduce the number of women with anaemia after birth (average RR 0.50, 95% CI 0.30 to 0.83, 2 studies, 1572 women; GRADE: low quality). We also found that active management of the third stage may make little or no difference to the number of babies admitted to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, 2 studies, 3207 infants; GRADE: low quality). It is uncertain whether active management of the third stage reduces the number of babies with jaundice requiring treatment (RR 0.96, 95% CI 0.55 to 1.68, 2 studies, 3142 infants, I = 66%; GRADE: very low quality). There were no data on our other primary outcomes of very severe PPH at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.Active management reduces mean maternal blood loss at birth and probably reduces the rate of primary blood loss greater than 500 mL, and the use of therapeutic uterotonics. Active management also probably reduces the mean birthweight of the baby, reflecting the lower blood volume from interference with placental transfusion. In addition, it may reduce the need for maternal blood transfusion. However, active management may increase maternal diastolic blood pressure, vomiting after birth, afterpains, use of analgesia from birth up to discharge from the labour ward, and more women returning to hospital with bleeding (outcome not pre-specified).In the comparison of women at low risk of excessive bleeding, there were similar findings, except it was uncertain whether there was a difference identified between groups for severe primary PPH (average RR 0.31, 95% CI 0.05 to 2.17; 2 studies, 2941 women, I = 71%), maternal Hb less than 9 g/dL at 24 to 72 hours (average RR 0.17, 95% CI 0.02 to 1.47; 1 study, 193 women) or the need for neonatal admission (average RR 1.02, 95% CI 0.55 to 1.88; 1 study, 1512 women). In this group, active management may make little difference to the rate of neonatal jaundice requiring phototherapy (average RR 1.31, 95% CI 0.78 to 2.18; 1 study, 1447 women).Hypertension and interference with placental transfusion might be avoided by using modifications to the active management package, for example, omitting ergot and deferring cord clamping, but we have no direct evidence of this here.
AUTHORS' CONCLUSIONS: Although the data appeared to show that active management reduced the risk of severe primary PPH greater than 1000 mL at the time of birth, we are uncertain of this finding because of the very low-quality evidence. Active management may reduce the incidence of maternal anaemia (Hb less than 9 g/dL) following birth, but harms such as postnatal hypertension, pain and return to hospital due to bleeding were identified.In women at low risk of excessive bleeding, it is uncertain whether there was a difference between active and expectant management for severe PPH or maternal Hb less than 9 g/dL (at 24 to 72 hours). Women could be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.It must be emphasised that this review includes only a small number of studies with relatively small numbers of participants, and the quality of evidence for primary outcomes is low or very low.
分娩第三产程的积极管理包括预防性使用宫缩剂、早期脐带结扎和控制性脐带牵拉以娩出胎盘。期待管理则是等待胎盘剥离迹象出现，然后胎盘自然娩出。引入积极管理是为了降低出血风险，出血是低收入国家孕产妇死亡的主要原因之一。这是对2015年发表的一篇综述的更新。
比较分娩第三产程积极管理与期待管理对严重原发性产后出血（PPH）及其他母婴结局的影响。比较分娩第三产程积极管理和期待管理方案的不同变化对严重原发性PPH及其他母婴结局的影响。
本次更新中，我们于2018年1月22日检索了Cochrane妊娠与分娩试验注册库、ClinicalTrials.gov及世界卫生组织国际临床试验注册平台（ICTRP），并检索了纳入研究的参考文献列表。
比较分娩第三产程积极管理与期待管理的随机对照试验和半随机对照试验。整群随机试验符合纳入标准，但未检索到相关试验。
两名综述作者独立评估研究是否纳入、评估偏倚风险、进行数据提取，并使用GRADE方法评估证据质量。
我们纳入了8项研究，涉及对8892名女性的数据进行分析。这些研究均在医院进行，7项在高收入国家，1项在低收入国家。4项研究比较了积极管理与期待管理；4项研究比较了积极管理与混合管理。由于存在临床异质性，我们在分析中使用了随机效应模型。在纳入的8项研究中，我们认为3项研究在序列产生、分配隐藏和数据收集完整性的主要方面偏倚风险较低。根据GRADE评估，我们的主要结局缺乏高质量证据，并在以下谨慎的表述中有所体现。证据表明，对于出血风险各异的女性，积极管理是否能降低分娩时产妇严重原发性PPH（超过1000 mL）的平均风险尚不确定（平均风险比（RR）0.34, 95%置信区间（CI）0.14至0.87, 3项研究, 4636名女性, I² = 60%; GRADE: 极低质量）。对于产后血红蛋白（Hb）低于9 g/dL的发生率，第三产程的积极管理可能会减少产后贫血女性的数量（平均RR 0.50, 95% CI 0.30至0.83, 2项研究, 1572名女性; GRADE: 低质量）。我们还发现，第三产程的积极管理对入住新生儿病房的婴儿数量可能几乎没有影响（平均RR 0.81, 95% CI 0.60至1.11, 2项研究, 3207名婴儿; GRADE: 低质量）。第三产程的积极管理是否能减少需要治疗黄疸婴儿的数量尚不确定（RR 0.96, 95% CI 0.55至1.68, 2项研究, 3142名婴儿, I² = 66%; GRADE: 极低质量）。对于我们其他主要结局，即分娩时极严重PPH（超过2500 mL）、孕产妇死亡率或需要治疗的新生儿红细胞增多症，没有相关数据。积极管理可减少分娩时产妇的平均失血量，可能降低原发性失血量超过500 mL的发生率以及宫缩剂的使用。积极管理还可能降低婴儿的平均出生体重，这反映了因干扰胎盘输血导致的血容量较低。此外，它可能减少产妇输血的需求。然而，积极管理可能会增加产妇舒张压、产后呕吐、产后疼痛、从分娩至离开产房期间镇痛剂的使用，以及更多女性因出血返回医院（该结局未预先设定）。在比较出血风险较低的女性时，有类似的发现，但对于严重原发性PPH（平均RR 0.31, 95% CI 0.05至2.17; 2项研究, 2941名女性, I² = 71%）、24至72小时时产妇Hb低于9 g/dL（平均RR 0.17, 95% CI 0.02至1.47; 1项研究, 193名女性）或新生儿入院需求（平均RR 1.02, 95% CI 0.55至1.88; 1项研究, 1512名女性），两组之间是否存在差异尚不确定。在这组女性中，积极管理对需要光疗的新生儿黄疸发生率可能影响不大（平均RR 1.31, 95% CI 0.78至2.18; 1项研究, 1447名女性）。通过对积极管理方案进行调整，例如省略麦角制剂和延迟脐带结扎，可能避免高血压和胎盘输血干扰，但我们在此没有直接证据。
尽管数据似乎显示积极管理降低了分娩时严重原发性PPH超过1000 mL的风险，但由于证据质量极低，我们对此发现并不确定。积极管理可能会降低产后产妇贫血（Hb低于9 g/dL）的发生率，但也发现了诸如产后高血压、疼痛和因出血返回医院等危害。在出血风险较低的女性中，积极管理与期待管理在严重PPH或产妇Hb低于9 g/dL（在24至72小时）方面是否存在差异尚不确定。可以向女性提供两种方法的利弊信息，以支持她们做出明智的选择。鉴于对早期脐带结扎的担忧以及某些宫缩剂的潜在不良反应，现在审视第三产程管理的各个组成部分至关重要。低收入国家也需要提供数据。必须强调本综述仅纳入了少量研究，参与者数量相对较少，主要结局的证据质量低或极低。
