Abou El Senoun Ghada, Dowswell Therese, Mousa Hatem A
Department of Obstetrics and Gynaecology, Queen's Medical Centre, Nottingham University Hospital, Derby Road, Nottingham, Nottinghamshire, UK, NG7 2UH.
Cochrane Database Syst Rev. 2010 Apr 14(4):CD008053. doi: 10.1002/14651858.CD008053.pub2.
Preterm prelabour rupture of membranes (PPROM) is associated with increased risk of maternal and neonatal morbidity and mortality. Women with PPROM have been predominantly managed in hospital. It is possible that selected women could be managed at home after a period of observation. The safety, cost and women's views about home management have not been established.
To assess the safety, cost and women's views about planned home versus hospital care for women with PPROM.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2010) and the reference lists of all the identified articles.
Randomised and quasi-randomised trials comparing planned home versus hospital management for women with PPROM before 37 weeks' gestation.
Two review authors independently assessed clinical trials for eligibility for inclusion, risk of bias, and carried out data extraction.
We included two trials (116 women) comparing planned home versus hospital management for PPROM. Overall, the number of included women in each trial was too small to allow adequate assessment of pre-specified outcomes. Investigators used strict inclusion criteria and in both studies relatively few of the women presenting with PPROM were eligible for inclusion. Women were monitored for 48 to 72 hours before randomisation. Perinatal mortality was reported in one trial and there was insufficient evidence to determine whether it differed between the two groups (risk ratio (RR) 1.93, 95% confidence interval (CI) 0.19 to 20.05). There was no evidence of differences between groups for serious neonatal morbidity, chorioamnionitis, gestational age at delivery, birthweight and admission to neonatal intensive care.There was no information on serious maternal morbidity or mortality. There was some evidence that women managed in hospital were more likely to be delivered by caesarean section (RR (random-effects) 0.28, 95% CI 0.07 to 1.15). However, results should be interpreted cautiously as there is a moderate heterogeneity for this outcome (I(2) = 35%). Mothers randomised to care at home spent approximately 10 fewer days as inpatients (mean difference -9.60, 95% CI -14.59 to -4.61) and were more satisfied with their care. Furthermore, home care was associated with reduced costs.
AUTHORS' CONCLUSIONS: The review included two relatively small studies that did not have sufficient statistical power to detect meaningful differences between groups. Future large and adequately powered randomised controlled trials are required to measure differences between groups for relevant pre-specified outcomes. Special attention should be given to the assessment of maternal satisfaction with care and cost analysis as they will have social and economic implications in both developed and developing countries.
胎膜早破(PPROM)与孕产妇和新生儿发病及死亡风险增加相关。患有PPROM的女性主要在医院接受治疗。经过一段时间的观察后,部分女性有可能在家中接受治疗。但目前尚未确定家庭治疗的安全性、成本以及女性对此的看法。
评估PPROM女性计划在家中治疗与在医院治疗的安全性、成本以及女性的看法。
我们检索了Cochrane妊娠与分娩组试验注册库(2010年1月)以及所有已识别文章的参考文献列表。
比较孕37周前PPROM女性计划在家中治疗与在医院治疗的随机和半随机试验。
两位综述作者独立评估临床试验是否符合纳入标准、偏倚风险,并进行数据提取。
我们纳入了两项试验(116名女性),比较PPROM的计划在家中治疗与在医院治疗。总体而言,每项试验中纳入的女性数量过少,无法充分评估预先设定的结局。研究人员使用了严格的纳入标准,在两项研究中,出现PPROM的女性中符合纳入条件的相对较少。女性在随机分组前接受了48至72小时的监测。一项试验报告了围产期死亡率,没有足够证据确定两组之间是否存在差异(风险比(RR)1.93,95%置信区间(CI)0.19至20.05)。两组在严重新生儿发病率、绒毛膜羊膜炎、分娩时的孕周、出生体重和入住新生儿重症监护病房方面没有差异的证据。没有关于严重孕产妇发病率或死亡率的信息。有一些证据表明,在医院接受治疗的女性更有可能通过剖宫产分娩(RR(随机效应)0.28,95%CI 0.07至1.15)。然而,由于该结局存在中度异质性(I(2)=35%),结果应谨慎解释。随机分组接受家庭治疗的母亲住院天数少约10天(平均差-9.60,95%CI -14.59至-4.61),并且对治疗更满意。此外,家庭治疗成本更低。
该综述纳入了两项相对较小的研究,没有足够的统计效力来检测两组之间有意义的差异。未来需要进行大型且有足够效力的随机对照试验,以测量两组在相关预先设定结局方面的差异。应特别关注对产妇对治疗的满意度评估和成本分析,因为它们在发达国家和发展中国家都将具有社会和经济影响。