Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Gestational age (GA) at birth
研究概览
简要总结
The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.
详细描述
The purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. In addition, the role of fetal fibronectin (fFN) for the prediction of preterm birth and hemorrhage will be elucidated. The hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Singleton pregnancy, ≥ 18yrs old
- •GA 18w0d to 26w0d inclusive @ time of enrollment
- •Documentation of complete placenta previa (≥ 10mm over internal os)
- •Agrees to participate in trial and signs/date an informed consent form.
排除标准
- •Contraindication to expectant management (i.e. active labor, Non-reassuring fetal heart rate (NRFHR), Intrauterine fetal demise (IUFD), uncontrolled hemorrhage)
- •Fetal condition likely to cause serious neonatal morbidity independent of GA (e.g. hydrops, fetal viral infections, fetal malformations likely to need surgery like hydrocephalus, neural tube defects, cardiac defects, abdominal wall defects)
- •Known uterine anomaly at time of enrollment
- •History of two or more prior cesarean deliveries
- •Suspected placenta accrete, increta or percreta on US at enrollment
- •Cervical cerclage present at time of enrollment
结局指标
主要结局
Gestational age (GA) at birth
时间窗: measure taken in the first 23 hours after birth.
The gestational age (GA) of the baby noted at birth
次要结局
- Newborn Birth weight(measured within 1-2 days after birth)
- Need for Maternal Blood Product replacement(measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks))
- Number of participants delivering prematurely following hemorrhage who have a positive fFN test.(measured at delivery)