METHODS: We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at <24 weeks of gestation and an asymptomatic short cervix of ≤25 mm or cervical dilatation will be randomly allocated (1:1) to both trials on vaginal cerclage and standard treatment according to the current Dutch Society of Obstetrics and Gynaecology guideline (no cerclage). Permuted blocks sized 2 and 4 will be used to minimise the risk of disbalance. The primary outcome measure is PTB of <28 weeks. Analyses will be by intention to treat. The first trial is to demonstrate a risk reduction from 25% to 10% in the short cervix group, for which 194 patients need to be recruited. The second trial is to demonstrate a risk reduction from 80% to 35% in the dilatation group and will recruit 44 women. A cost-effectiveness analysis will be performed from a societal perspective.
BACKGROUND: This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.
BACKGROUND: ClinicalTrials.gov, NCT05968794.
方法:我们设计了两项多中心随机试验,涉及荷兰的8家医院(其他国家的研究点可能会在以后添加)。根据目前的荷兰妇产科协会指南(无环扎),16岁以上双胎妊娠且无症状宫颈短≤25mm或宫颈扩张的女性将被随机分配(1:1)进行阴道环扎和标准治疗的两项试验。大小为2和4的置换块将用于最小化失衡的风险。主要结果测量是<28周的PTB。分析将通过意向治疗。第一个试验是证明短宫颈组的风险从25%降低到10%,需要招募194名患者。第二项试验表明,扩张组的风险从80%降低到35%,并将招募44名女性。将从社会角度进行成本效益分析。
背景:这项研究已于2023年3月30日获得荷兰研究伦理委员会的批准。参与者将被要求签署知情同意书。结果将在会议上发表,并在同行评审的期刊上发表。参与者将被告知结果。
背景:ClinicalTrials.gov,NCT05968794。