孕34至37周胎膜早破孕妇引产与期待治疗的比较（PPROMEXIL试验）
Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial).
作者信息
van der Ham David P, Nijhuis Jan G, Mol Ben Willem J, van Beek Johannes J, Opmeer Brent C, Bijlenga Denise, Groenewout Mariette, Arabin Birgit, Bloemenkamp Kitty W M, van Wijngaarden Wim J, Wouters Maurice G A J, Pernet Paula J M, Porath Martina M, Molkenboer Jan F M, Derks Jan B, Kars Michael M, Scheepers Hubertina C J, Weinans Martin J N, Woiski Mallory D, Wildschut Hajo I J, Willekes Christine
机构信息
Department of Obstetrics and Gynaecology, VieCuri Medical Centre Venlo, the Netherlands.
出版信息
BMC Pregnancy Childbirth. 2007 Jul 6;7:11. doi: 10.1186/1471-2393-7-11.
BACKGROUND
Preterm prelabour rupture of the membranes (PPROM) is an important clinical problem and a dilemma for the gynaecologist. On the one hand, awaiting spontaneous labour increases the probability of infectious disease for both mother and child, whereas on the other hand induction of labour leads to preterm birth with an increase in neonatal morbidity (e.g., respiratory distress syndrome (RDS)) and a possible rise in the number of instrumental deliveries.
METHODS/DESIGN: We aim to determine the effectiveness and cost-effectiveness of immediate delivery after PPROM in near term gestation compared to expectant management. Pregnant women with preterm prelabour rupture of the membranes at a gestational age from 34+0 weeks until 37+0 weeks will be included in a multicentre prospective randomised controlled trial. We will compare early delivery with expectant monitoring. The primary outcome of this study is neonatal sepsis. Secondary outcome measures are maternal morbidity (chorioamnionitis, puerperal sepsis) and neonatal disease, instrumental delivery rate, maternal quality of life, maternal preferences and costs. We anticipate that a reduction of neonatal infection from 7.5% to 2.5% after induction will outweigh an increase in RDS and additional costs due to admission of the child due to prematurity. Under these assumptions, we aim to randomly allocate 520 women to two groups of 260 women each. Analysis will be by intention to treat. Additionally a cost-effectiveness analysis will be performed to evaluate if the cost related to early delivery will outweigh those of expectant management. Long term outcomes will be evaluated using modelling.
DISCUSSION
This trial will provide evidence as to whether induction of labour after preterm prelabour rupture of membranes is an effective and cost-effective strategy to reduce the risk of neonatal sepsis. CONTROLLED CLINICAL TRIAL REGISTER: ISRCTN29313500.
背景
胎膜早破（PPROM）是一个重要的临床问题，也是妇科医生面临的两难困境。一方面，等待自然分娩会增加母婴感染疾病的概率；另一方面，引产会导致早产，增加新生儿发病率（如呼吸窘迫综合征（RDS）），并可能增加器械助产的数量。
方法/设计：我们旨在确定与期待治疗相比，近足月妊娠胎膜早破后立即分娩的有效性和成本效益。孕周从34+0周直到37+0周的胎膜早破孕妇将被纳入一项多中心前瞻性随机对照试验。我们将早期分娩与期待监测进行比较。本研究的主要结局是新生儿败血症。次要结局指标包括孕产妇发病率（绒毛膜羊膜炎、产褥期败血症）和新生儿疾病、器械助产率、孕产妇生活质量、孕产妇偏好和成本。我们预计引产术后新生儿感染率从7.5%降至2.5%的益处将超过因早产导致新生儿呼吸窘迫综合征增加以及因新生儿入院带来的额外成本。在这些假设下，我们旨在将520名女性随机分配到两组，每组260名女性。分析将按照意向性分析进行。此外，将进行成本效益分析，以评估早期分娩的相关成本是否超过期待治疗的成本。长期结局将通过建模进行评估。
讨论
本试验将提供证据，证明胎膜早破后引产是否是降低新生儿败血症风险的有效且具有成本效益的策略。
对照临床试验注册
ISRCTN29313500。
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