PDF(Pubmed)
Abstract：
BACKGROUND: Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.
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.
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.
摘要：
背景：双胎妊娠在妊娠不到28周时发生极端早产（PTB）的风险很高，这与新生儿发病和死亡的风险增加有关。目前，对于双胎妊娠和宫颈短或宫颈扩张的妇女，缺乏有效的治疗方法。在妊娠中期无症状的子宫颈短或扩张的双胎妊娠中，减少极端PTB的一种可能有效的手术方法是放置阴道环扎术。
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。
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。
