RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 238
- 主要终点
- Percentage of spontaneous vaginal delivery
研究概览
简要总结
Introduction:
The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. The manual rotation to promote rotation from a posterior to an anterior position has been proposed to reduce the extraction rate. There is no randomised trial comparing the effect of manual rotation and expectant management. We propose a protocol for a prospective, monocentric, randomised controlled clinical trial in order to show that the rate of spontaneous vaginal delivery is higher with manual rotation of occiput posterior position than with an expectative management.
Methods:
Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible. Participants will be randomised to either prophylactic manual rotation (experimental group) or expectative management (control group). Based on an alpha value of 0.05 and gaining 20% for spontaneous vaginal delivery, 238 participants will need to be enrolled.
The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be operative delivery rate (caesarean section , vacuum or forceps deliveries), significant maternal and perinatal mortality/morbidity.
Analysis will be by intention-to-treat averaging a 24-month period.
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
- •Inclusion Criteria:
- •age ≥ 18 years
- •singleton pregnancy
- •≥37 weeks of gestation
- •planned vaginal birth
- •cephalic presentation
- •occiput posterior position confirmed by ultrasound at full dilatation
排除标准
- •withdrawal of consent
结局指标
主要结局
Percentage of spontaneous vaginal delivery
时间窗: At the time of delivery
次要结局
未报告次要终点
