Hansen Lea Kirstine, Krogh Lise Qvirin, Lantto Annie, Uldbjerg Niels, Jensen Pernille Tine, Shennan Andrew, Hald Kirsten, Heikinheimo Oskari, Jacobsson Bo, Hjartardóttir Hulda, Karypidis Helena, Glavind Julie
Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark
Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
BMJ Open. 2025 Sep 23;15(9):e107093. doi: 10.1136/bmjopen-2025-107093.
Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.
The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth <32 weeks of gestation. A total sample of 188 participants will be included to detect an absolute difference of 15% in the primary outcome between the two groups. Analysis will be by intention-to-treat.
The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.
NCT06122506.
经阴道和经腹宫颈环扎术已成为预防孕中期流产和早产的既定干预措施。对于有经阴道宫颈环扎术失败史的女性，经腹宫颈环扎术似乎优于经阴道宫颈环扎术。然而，随着侵入性较小的腹腔镜手术的出现，对于向许多其他风险组推荐哪种类型的宫颈环扎术，证据有限。本试验的目的是比较腹腔镜下经腹宫颈环扎术和经阴道宫颈环扎术在自发性早产中、高风险女性中的效果。
该试验是一项开放、多中心、优效性、平行组随机对照研究者发起的试验，包含一个嵌入式内部预试验。临床医生在腹腔镜和经阴道宫颈环扎术之间存在临床 equipoise 的女性，将以 1:1 的比例随机分配接受腹腔镜下经腹或经阴道宫颈环扎术。该试验在丹麦、芬兰和挪威的多个地点开展。主要结局是妊娠 <32 周分娩。将纳入总共 188 名参与者，以检测两组在主要结局上 15% 的绝对差异。分析将采用意向性分析。
丹麦中日德兰地区生物医学研究伦理委员会、芬兰赫尔辛基大学医院伦理委员会以及挪威医学与健康研究伦理地区委员会批准了该试验。本方案在完成数据收集和分析之前发表。重要的方案变更将在 ClinicalTrials.org、试验网站上公开提供，并以电子方式分发给所有活跃站点。该试验的阳性、不确定以及阴性结果将发表在同行评审的国际科学期刊上。
NCT06122506 。
