Cerclage vs Cervical Pessary in Women With Cervical Incompetence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Spontaneous delivery before 34 complete weeks
研究概览
简要总结
Cervical insufficiency (CI), responsible for 8% of preterm births (PB), is used to describe painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies. Structural weakness of cervical tissue was thought to cause or contribute to these adverse outcomes. The term has also been applied to women with one or two such losses/births or at risk for second-trimester pregnancy loss/birth. Cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for PB. This study aims to demonstrate that the cervical pessary could reduce the preterm birth rate before 37 weeks of gestation in women with prior PB due to cervical insufficiency or in women with prior PB and a short cervix in the current pregnancy.
详细描述
Methods/Design: This is an open-label, pilot, multicentre, prospective, randomised controlled trial (RCT). Enrolees are women with singleton pregnancies and previous PB based on CI (primary intervention, <16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, <24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment. The primary outcome is the spontaneous preterm birth rate before 34 weeks of gestation. The sample size was calculated, as a pilot study, based on the estimated population that we will be able to recruit during the duration of the trial: 60 women, 30 for each group (cervical cerclage and cervical pessary group) to observe, at least a reduction in the PB rate < 34 weeks from 34% to 27% in the pessary group, as does cerclage.
Discussion: The outcome of this study will show the effectiveness of a cervical cerclage and of a cervical pessary in this group of patients.
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
- •Singleton pregnancy
- •Minimum age: 18 years
- •Previous PB based on CI (primary intervention, <16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, <24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment.
排除标准
- •Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- •Threatened preterm labour at time of randomization
- •Spontaneous rupture of membranes at time of randomization
- •Chorioamnionitis at time of randomization
- •Active vaginal bleeding
- •Placenta previa
结局指标
主要结局
Spontaneous delivery before 34 complete weeks
时间窗: Before 34 weeks of gestation
Spontaneous delivery before 34 complete weeks
次要结局
- Maternal side effects(During pregnancy)
- Neonatal morbidity(28 days of newborn or during NICU stay)
- Number of participants with chorioamnionitis infection(During pregnancy)
- Spontaneous delivery before 37 complete weeks(Before 37 weeks of gestation)
- Maternal morbidity(during pregnancy)
- Spontaneous delivery before 28 complete weeks(Before 28 weeks of gestation)
- Foetal and neonatal death(During pregnancy and during the first 28 days of newborn or NICU stay)
- Hospitalisation for threatened preterm labour(During pregnancy)
研究者
Maria Goya, MD, PhD
PhD
Maternal-Infantil Vall d´Hebron Hospital