Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial
Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial
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DOI：
10.1016/s0140-6736(15)00724-2
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发表时间：
2016-01-30
期刊：
影响因子：
168.9
通讯作者：
Crowther, Caroline A.
中科院分区：
文献类型：
--
作者：
Morris, Jonathan M.;Roberts, Christine L.;Crowther, Caroline A.
背景：接近足月的早产前胎膜破裂与新生儿感染风险增加相关，但立即分娩与早产风险相关。风险的平衡尚不清楚。我们的目标是确定胎膜破裂的单胎孕妇在接近足月时立即分娩是否在不增加其他发病率的情况下减少新生儿感染。方法PPROMT试验是一项多中心随机对照试验，在11个国家的65个中心进行。年龄超过16岁的单胎妊娠和分娩开始前胎膜破裂的妇女包括在34周到36周和6天之间没有感染迹象的妇女。通过计算机生成的随机分组计划(1：1)，妇女被随机分配到即时分娩或待产期管理，其中分组大小可变，按中心分层。主要结果是新生儿败血症的发生率。二次婴儿结局包括新生儿发病率和死亡率的综合指标(即败血症、机械通气和GT；=24小时、死产或新生儿死亡)；呼吸窘迫综合征；任何机械呼吸；以及在新生儿重症监护病房或特别护理病房停留的时间。次要产妇结局包括产前或产中出血、产中发热、产后抗生素治疗和分娩方式。女性和照顾者不能被遮盖，但那些对主要结果做出裁决的人被遮盖到小组分配中。通过意向治疗进行分析。这项试验在国际临床试验注册中心注册，编号为ISRCTN44485060。结果在2004年5月28日至2013年6月30日期间，招募了1839名女性并随机分配：924名立即出生组，915名待产管理组。直接分娩组中的一名妇女和待产组中的三名妇女被排除在初步分析之外。在923名母亲立即出生的新生儿中有23名(2%)发生了新生儿败血症，而在912名接受期待治疗的母亲中有29名新生儿(3%)发生了新生儿败血症(相对危险度[RR]0.8，95%可信区间0.5-1.3；p=0.37)。在923名立即分娩的母亲和911名接受期待治疗的母亲的新生儿中，73名(8%)和61名(7%)发生了新生儿发病率和死亡率的综合次级结果(RR 1.2，95%CI 0.9-1.6；p=0.32)。然而，即时分娩组母亲所生新生儿呼吸窘迫的发生率(919例中76例[8%]vs910例47例[5%]，RR 1.6，95%CI1.1-2.30；p=0.008)和任何机械通气者(923例中114例[12%]vs912例中83例[9%]，RR 1.4，95%CI1.0-1.8；P=0.02)，并在重症监护病房花费更多的时间(中位数4.0天[IQR 0.0-10.0]对2.0天[0.0-7.0]；p
Background Preterm pre-labour ruptured membranes close to term is associated with increased risk of neonatal infection, but immediate delivery is associated with risks of prematurity. The balance of risks is unclear. We aimed to establish whether immediate birth in singleton pregnancies with ruptured membranes close to term reduces neonatal infection without increasing other morbidity.Methods The PPROMT trial was a multicentre randomised controlled trial done at 65 centres across 11 countries. Women aged over 16 years with singleton pregnancies and ruptured membranes before the onset of labour between 34 weeks and 36 weeks and 6 days weeks who had no signs of infection were included. Women were randomly assigned (1: 1) by a computer-generated randomisation schedule with variable block sizes, stratified by centre, to immediate delivery or expectant management. The primary outcome was the incidence of neonatal sepsis. Secondary infant outcomes included a composite neonatal morbidity and mortality indicator (ie, sepsis, mechanical ventilation >= 24 h, stillbirth, or neonatal death); respiratory distress syndrome; any mechanical ventilation; and duration of stay in a neonatal intensive or special care unit. Secondary maternal outcomes included antepartum or intrapartum haemorrhage, intrapartum fever, postpartum treatment with antibiotics, and mode of delivery. Women and caregivers could not be masked, but those adjudicating on the primary outcome were masked to group allocation. Analyses were by intention to treat. This trial is registered with the International Clinical Trials Registry, number ISRCTN44485060.Findings Between May 28, 2004, and June 30, 2013, 1839 women were recruited and randomly assigned: 924 to the immediate birth group and 915 to the expectant management group. One woman in the immediate birth group and three in the expectant group were excluded from the primary analyses. Neonatal sepsis occurred in 23 (2%) of 923 neonates whose mothers were assigned to immediate birth and 29 (3%) of 912 neonates of mothers assigned to expectant management (relative risk [RR] 0.8, 95% CI 0.5-1.3; p=0.37). The composite secondary outcome of neonatal morbidity and mortality occurred in 73 (8%) of 923 neonates of mothers assigned to immediate delivery and 61 (7%) of 911 neonates of mothers assigned to expectant management (RR 1.2, 95% CI 0.9-1.6; p=0.32). However, neonates born to mothers in the immediate delivery group had increased rates of respiratory distress (76 [8%] of 919 vs 47 [5%] of 910, RR 1.6, 95% CI 1.1-2.30; p=0.008) and any mechanical ventilation (114 [12%] of 923 vs 83 [9%] of 912, RR 1.4, 95% CI 1.0-1.8; p=0.02) and spent more time in intensive care (median 4.0 days [IQR 0.0-10.0] vs 2.0 days [0.0-7.0]; p