孕中期未足月胎膜早破（PPROM）：期待治疗或羊膜腔灌注以改善围产期结局（PPROMEXIL - III试验）
Midtrimester preterm prelabour rupture of membranes (PPROM): expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL - III trial).
作者信息
van Teeffelen Augustinus S P, van der Ham David P, Willekes Christine, Al Nasiry Salwan, Nijhuis Jan G, van Kuijk Sander, Schuyt Ewoud, Mulder Twan L M, Franssen Maureen T M, Oepkes Dick, Jansen Fenna A R, Woiski Mallory D, Bekker Mireille N, Bax Caroline J, Porath Martina M, de Laat Monique W M, Mol Ben W, Pajkrt Eva
机构信息
Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, P, Debijelaan 25, 6229 HX Maastricht, The Netherlands.
出版信息
BMC Pregnancy Childbirth. 2014 Apr 4;14:128. doi: 10.1186/1471-2393-14-128.
BACKGROUND
Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome.
METHODS/DESIGN: Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial.
INTERVENTION
random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05).
DISCUSSION
This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure.
TRIAL REGISTRATION
NTR3492 Dutch Trial Register (http://www.trialregister.nl).
背景
孕中期胎膜早破（PPROM）后出生的婴儿有发生新生儿肺发育不全的风险。这种并发症后的围产期死亡率和发病率很高。PPROM后孕中期羊水过少被认为会导致肺发育延迟。反复经腹羊膜腔灌注以缓解羊水过少可能预防这种并发症并可能改善新生儿结局。
方法/设计：孕周在16至24周之间、患有PPROM且持续羊水过少的女性将被邀请参加一项多中心随机对照试验。
干预措施
随机分配至（反复）经腹羊膜腔灌注（干预组）或期待治疗（对照组）。主要结局是围产期死亡率。次要结局包括致死性肺发育不全、非致死性肺发育不全、存活至从新生儿重症监护病房出院、新生儿死亡率、慢性肺病（CLD）、通气支持天数、坏死性小肠结肠炎（NEC）、I级以上脑室周围白质软化（PVL）、II级以上严重脑室内出血（IVH）、确诊的新生儿败血症、分娩时的孕周、分娩时间、分娩指征、羊膜腔灌注成功、胎盘早剥、脐带脱垂、绒毛膜羊膜炎、穿刺导致的胎儿创伤。该研究将根据意向性分析进行评估。为了显示围产期死亡率从70%降至35%，我们需要将两组各28名女性随机分组（双侧检验，β错误概率0.2，α错误概率0.05）。
讨论
本研究将回答孕中期PPROM合并羊水过少后（反复）经腹羊膜腔灌注是否能提高围产期存活率并预防肺发育不全和其他新生儿疾病这一问题。此外，它还将评估该操作相关的风险。
试验注册
NTR3492荷兰试验注册库（http://www.trialregister.nl）
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