Morris Jonathan M, Roberts Christine L, Crowther Caroline A, Buchanan Sarah L, Henderson-Smart David J, Salkeld Glenn
Department of Obstetrics and Gynaecology, Royal North Shore Hospital, St Leonards, NSW 2065, Australia.
BMC Pregnancy Childbirth. 2006 Mar 23;6:9. doi: 10.1186/1471-2393-6-9.
Preterm prelabour rupture of membranes (PPROM) complicates up to 2% of all pregnancies and is the cause of 40% of all preterm births. The optimal management of women with PPROM prior to 37 weeks, is not known. Furthermore, diversity in current clinical practice suggests uncertainty about the appropriate clinical management. There are two options for managing PPROM, expectant management (a wait and see approach) or early planned birth. Infection is the main risk for women in which management is expectant. This risk need to be balanced against the risk of iatrogenic prematurity if early delivery is planned. The different treatment options may also have different health care costs. Expectant management results in prolonged antenatal hospitalisation while planned early delivery may necessitate intensive care of the neonate for problems associated with prematurity.
METHODS/DESIGN: We aim to evaluate the effectiveness of early planned birth compared with expectant management for women with PPROM between 34 weeks and 366 weeks gestation, in a randomised controlled trial. A secondary aim is a cost analysis to establish the economic impact of the two treatment options and establish the treatment preferences of women with PPROM close to term. The early planned birth group will be delivered within 24 hours according to local management protocols. In the expectant management group birth will occur after spontaneous labour, at term or when the attending clinician feels that birth is indicated according to usual care. Approximately 1812 women with PPROM at 34-366 weeks gestation will be recruited for the trial. The primary outcome of the study is neonatal sepsis. Secondary infant outcomes include respiratory distress, perinatal mortality, neonatal intensive care unit admission, assisted ventilation and early infant development. Secondary maternal outcomes include chorioamnionitis, postpartum infection treated with antibiotics, antepartum haemorrhage, induction of labour, mode of delivery, maternal satisfaction with care, duration of hospitalisation, and maternal wellbeing at four months postpartum.
This trial will provide evidence on the optimal care for women with PPROM close to term (34-37 weeks gestation). Consideration of both the clinical and economic sequelae of the management of PPROM will enable informed decision making and guideline development.
胎膜早破（PPROM）在所有妊娠中发生率高达2%，是所有早产病例中40%的病因。孕37周前PPROM女性的最佳管理方案尚不清楚。此外，当前临床实践的多样性表明，对于适当的临床管理存在不确定性。PPROM的管理有两种选择，期待治疗（等待观察法）或早期计划分娩。感染是期待治疗女性面临的主要风险。这种风险需要与计划早期分娩时医源性早产的风险相权衡。不同的治疗方案可能也会有不同的医疗费用。期待治疗会导致产前住院时间延长，而计划早期分娩可能因早产相关问题而需要对新生儿进行重症监护。
方法/设计：我们旨在通过一项随机对照试验，评估孕34周和36⁺⁶周之间PPROM女性早期计划分娩与期待治疗相比的有效性。次要目标是进行成本分析，以确定两种治疗方案的经济影响，并确定接近足月的PPROM女性的治疗偏好。早期计划分娩组将根据当地管理方案在24小时内分娩。在期待治疗组中，分娩将在自然分娩后、足月时或主治医生根据常规护理认为需要分娩时进行。大约1812名孕34 - 36⁺⁶周的PPROM女性将被纳入该试验。该研究的主要结局是新生儿败血症。次要婴儿结局包括呼吸窘迫、围产期死亡率、新生儿重症监护病房入院、辅助通气和早期婴儿发育。次要母亲结局包括绒毛膜羊膜炎、用抗生素治疗的产后感染、产前出血、引产、分娩方式、母亲对护理的满意度、住院时间以及产后四个月时的母亲健康状况。
这项试验将为接近足月（孕34 - 37周）的PPROM女性的最佳护理提供证据。考虑PPROM管理的临床和经济后果将有助于做出明智的决策并制定指南。
