Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 309
- 试验地点
- 23
- 主要终点
- Take-home baby rate
研究概览
简要总结
The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.
详细描述
Cervical weakness and ascending infection have long been considered important causes of preterm birth. Cervical occlusion could theoretically be used for the treatment of cervical weakness and to protect the cervix against infection. A cervical cerclage could be placed to increase the cervical resistance, and occlusion of the external os could be performed to retain the cervical mucus plug thereby preventing infection. The aim of this multicentre, stratified, randomised controlled trial was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with prophylactic and therapeutic cervical cerclages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The physician in charge considered that a cerclage was indicated.
- •Gestational age between 12 and 27 completed weeks.
- •Previous late mid-trimester miscarriage, or spontaneous preterm labour and delivery before 28 weeks with or without previous cerclages.
- •Previous cerclage because of short cervix.
- •Confirmed gestational age defined as gestational age estimated by ultrasound at less than or equal to 22+0 weeks, and/or certain last menstrual period.
- •Vaginal infection treated before cerclage.
- •Ability to read and understand the relevant national language.
- •Consent obtained in accordance with specifications of the local research ethics committee.
- •18 years or more of age and legally competent.
排除标准
- •Demonstrated cervical infection.
- •Obstetrical complications in the current pregnancy.
- •Multiple pregnancies.
- •History of a significant abruptio placenta in a previous pregnancy.
结局指标
主要结局
Take-home baby rate
时间窗: Neonates will be followed for the duration of stay in the neonatal intensive care unit, an expected average of 28 days with a minimum of 0 days up to a maximum of 98 days.
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
次要结局
- Gestational age at birth(At birth)
研究者
Niels Jørgen Secher
Professor
Hvidovre University Hospital