Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 182
- 试验地点
- 14
- 主要终点
- cesarean delivery rate
研究概览
简要总结
Ultrasound during labor and measurement of Angle of progression showed extensive prospective and retrospective publications since 2010. The investigators performed between 2013 and 2016 the only one multicenter, randomized controlled Trial comparing digital exam to angle of progression after a prolonged 2-hour second stage of labor with uncertain fetal head. The investigators consider a cut off of 120° to accepted vaginal birth among cephalic occiput anterior position This randomised PILOT study showed that measurement of Angle of progression in addition to digital exam reduced caesarean delivery from 41% to12% ( n= 33, p=0,06). doi: 10.1016/j.ajog.2022.04.018.
The objective of this new study is therefore to validate the results of this PILOT study in a more powerful multicenter randomized trial (DELIVERY).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Nulliparous or multiparous women with no history of vaginal delivery,
- •> or = 37 weeks amenorrhoea
- •Cephalic presentation in anterior position (occipito-pubic position, left anterior occipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound
- •uncertain fetal head engagement on digital examination or midline fetal presentation in prolonged second stage of labor (at least 2 hours),
排除标准
- •Multiparous women who were previous vaginal deliveries,
- •Presentation other than cephalic,
- •Twin pregnancies,
- •Posterior or transverse position
- •Transperineal ultrasound for head-perineum distance measurement
- •Fetal heart rate abnormalities requiring rapid delivery,
- •Contraindication to vaginal delivery whether maternal or fetal
结局指标
主要结局
cesarean delivery rate
时间窗: baseline
Demonstrate that the angle of progression measurement would change by 20% the cesarean rate after a prolonged second stage of labor (2 hours).
次要结局
- Severe neonatal morbidity, in each group(1 month)
- Number of complicated deliveries in each group(baseline)
- Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading(1 month)
- Severe maternal morbidity, in each group(1 month)
- Rate of admission to neonatal intensive care unit, in each group(1 month)