Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage: an Observational Study in a Danish Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- Neonatal survival (defined as survival at time of discharge from hospital)
研究概览
简要总结
Preterm birth is a leading cause of neonatal mortality and morbidity. Cervical insufficiency is one factor implicated in the complex mechanisms involved in spontaneous preterm birth. Trans-abdominal insertion of a cervical cerclage suture can be used to treat cervical insufficiency. Growing evidence support that laparoscopic cerclage procedures are safe and effective. Still, many aspects of the laparoscopic cerclage remains uncertain. Therefore, the investigators plan to study the obstetric outcome from the first and subsequent pregnancies after laparoscopic cerclage in a Danish cohort from Aarhus University Hospital in a 10 years' period.
详细描述
Please see attached study protocol for further desricption.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Persons who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark between May 2011 and May 2021
排除标准
- •Persons who had their laparoscopic cerclage performed subsequently to a trachelectomy.
结局指标
主要结局
Neonatal survival (defined as survival at time of discharge from hospital)
时间窗: From birth until discharge, an average of 8 weeks
no. (reported for first, and consecutive deliveries)
次要结局
- Number of uterine ruptures(From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends))
- Time to first pregnancy (years and days)(From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends))
- Number of neonates surviving with major neonatal morbidity(From birth until discharge, an average of 8 weeks)
- Number of pregnancies(From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends))
- Number of miscarriages(From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends))
- Deliveries(From birth until discharge, an average of 8 weeks)