Mediolateral Episiotomy and Prevention of Obstetric Anal Sphincter Injuries in Instrumental Delivery: a Prospective Population-based Propensity Score Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument)
研究概览
简要总结
Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidelines. The investigators consider that a randomized trials does not appears feasible for both ethical and practical reason and so we suggest a large national observational study.
The investigators will include all nulliparous women that underwent an operative vaginal delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The investigators will collect data about the history of pregnancy, the course of labor, the mode of delivery, maternal immediate and one-year morbidity, neonatal immediate morbidity. The investigators expect a one-year study in 129 recruiting center with 15000 included women.
The primary objective is to assess the protective effect of mediolateral episiotomy against obstetric anal sphincter injury during instrumental delivery in nulliparous women according to the type of instrument used. The secondary endpoints are to investigate the effect of mediolateral episiotomy on one-year maternal morbidity, immediate maternal morbidity. The investigators also aim to develop a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery. Finally, the investigators will investigate the impact of fetal presentation ultrasound assessment immediately before instrumental delivery on the mode of delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age of 18 years or older
- •nulliparity and instrumental delivery of a singleton in cephalic presentation in the previous 72 hours including failure of vaginal instrumental delivery leading to cesarean section
排除标准
- •expression of any opposition or objection to study participation
- •previous delivery of a fetus at a gestational age greater than 20 weeks, regardless of the mode of delivery
- •preterm birth before 34 weeks of amenorrhea
- •fetal presentation other than cephalic
- •multiple pregnancy
- •in utero death
- •inability to understand French
- •under judicial protection
- •without access to a numeric terminal with internet connexion
结局指标
主要结局
Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument)
时间窗: Immediately after the delivery
Perineal tears involving the anal sphincter complex (3rd and 4th degree according RCOG OMS classification)
次要结局
- Immediate neonatal morbidity (mediolateral episiotomy versus no episiotomy)(through mother's hospitalization, an average of 4 days)
- Association between fetal presentation assessment before the delivery and the issue of delivery (ultrasound assessment versus no ultrasound assessment)(through mother's hospitalization, an average of 4 days)
- Development of a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery (with or without mediolateral episiotomy)(through mother's hospitalization, an average of 4 days)
- Immediate maternal morbidity (mediolateral episiotomy vs no episiotomy)(through mother's hospitalization, an average of 4 days)
- One year maternal morbidity (mediolateral episiotomy versus no episiotomy)(1 year)