Maternal & Fetal Medicine, Mater Medical Research Institute, South Brisbane, Queensland, Australia
NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2024 Sep 28;14(9):e082943. doi: 10.1136/bmjopen-2023-082943.
We showed in a phase II randomised controlled trial (RCT) that oral sildenafil citrate in term labour halved operative birth for fetal distress. We outline the protocol for a phase III RCT (can ntrapartum ildnafil safely vert the isks of ontraction-induced ypoxia? (iSEARCH)) of 3200 women in Australia to assess if sildenafil citrate reduces adverse perinatal outcomes related to intrapartum hypoxia.
iSEARCH will enrol 3200 Australian women in term labour to determine whether up to three 50 mg oral doses of sildenafil citrate versus placebo reduce the relative risk of a primary composite end point of 10 perinatal outcomes potentially related to intrapartum hypoxia by 35% (from 7% to 4.55%). Secondary aims are to evaluate reductions in the relative risk of emergency caesarean section or instrumental vaginal birth for fetal distress by 25% (from 20% to 15%) and in healthcare costs. To detect a 35% reduction in the primary outcome for an alpha of 0.05 and power of 80% with 10% dropout in each arm requires 3200 women (1600 in each arm). This sample size will also yield >90% power to detect a 25% reduction for the secondary outcome of any operative birth (caesarean section or instrumental vaginal birth) for fetal distress.
Ethical approval for the iSEARCH RCT was granted by the Hunter New England Human Research Ethics Committee (ref no: 2020/ETH02791). Results will be disseminated through websites, peer-reviewed publications, scientific meetings and social media, news outlets, television and radio.
ACTRN12621000231842.
我们在一项 II 期随机对照试验（RCT）中表明，在足月分娩时口服枸橼酸西地那非可将因胎儿窘迫而行剖宫产的比例减半。我们概述了一项 III 期 RCT（can ntrapartum ildnafil safely vert the isks of ontraction-induced ypoxia? (iSEARCH)）的方案，该 RCT 将在澳大利亚招募 3200 名足月分娩的妇女，以评估枸橼酸西地那非是否能降低与产时缺氧相关的不良围产结局。
iSEARCH 将招募 3200 名澳大利亚足月分娩的妇女，以确定多达三次 50mg 口服枸橼酸西地那非与安慰剂相比是否能将与产时缺氧相关的 10 个潜在围产结局的主要复合终点的相对风险降低 35%（从 7%降至 4.55%）。次要目标是评估减少因胎儿窘迫而行紧急剖宫产术或器械性阴道分娩的相对风险降低 25%（从 20%降至 15%）和医疗保健成本。为了在每个臂的 10%脱落率下达到 0.05 的 alpha 值和 80%的功效，需要 3200 名妇女（每个臂 1600 名）来检测主要结局的 35%的降低。该样本量还将有超过 90%的功效来检测次要结局中因胎儿窘迫而行任何手术分娩（剖宫产术或器械性阴道分娩）的 25%的降低。
iSEARCH RCT 的伦理批准由亨特新英格兰人类研究伦理委员会授予（编号：2020/ETH02791）。结果将通过网站、同行评议出版物、科学会议和社交媒体、新闻媒体、电视和广播进行传播。
ACTRN12621000231842。
