The Optimal Timing for Cerclage Removal
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Cercalge removal and neonatal morbidity
研究概览
简要总结
Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery
详细描述
The optimal timing of cervical cerclage removal is yet unclear.
In the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/
Primary outcome:
Neonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks).
Secondary outcomes:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancies
- •Elective or emergent cerclage in the current pregnancy
- •Cerclage that was removed after 36 weeks of pregnancy
排除标准
- •Multiple pregnancies
- •Major congenital anomalies
- •Cerclage removal before 36weeks of pregnancy
结局指标
主要结局
Cercalge removal and neonatal morbidity
时间窗: 1 year
Neonatal respiratory morbidity after cerclage removal
次要结局
- The optimal timing for cerclage removal(1 year)
研究者
Yaniv Zipori MD
Principal Investigator
Rambam Health Care Campus