Trial of Prophylactic Manual Rotation of Persistent Occiput Posterior Presentation During the Early Second Stage of Labor to Reduce Operative Delivery: a Prospective Multicenter Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Number of patients who will have a caesarean section or an instrumental delivery in each groups.
研究概览
简要总结
Superiority multicenter prospective randomized study on operative delivery (instrumental delivery or caesarean section) of prophylactic manual rotation in case of persistent occipital posterior presentation during the second stage of labor compared to expectant management. A 15% reduction of operative delivery (instrumental delivery or caesarean section) is attempt in the prophylactic manual rotation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years
- •Singleton pregnancy
- •Term ≥ 37 weeks of gestation
- •Early second stage of labor
- •Rupture membranes
- •Persistent occiput posterior position confirmed by ultrasound
- •Epidural anesthesia
- •Patient who agree to participate and sign consent form
排除标准
- •Age < 18 years
- •Term < 37 weeks of gestation
- •Vaginal and instrumental Delivery maternal contraindication
- •Antecedent of perineal injury type IV
- •Sensitive perineum
- •Crohn's disease with vaginal delivery contraindication
- •Instrumental fetal contraindication
- •Non reassuring fetal heart with impossibility of optimal maternal information
- •Known fetal malformation
- •Previous ceaserean section
- •Non cephalic presentation
- •Not affiliated to social security
研究组 & 干预措施
No prophylactic manual rotation group
During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed
prophylactic manual rotation group
During persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed.
干预措施: Prophylactic Manual Rotation of persistent occipital posterior presentation (Procedure)
结局指标
主要结局
Number of patients who will have a caesarean section or an instrumental delivery in each groups.
时间窗: 4 hours
次要结局
- Number of patients with episiotomy, perineal lacerations from the 1st to the 4rth degree anglo-saxon classification(4 hours)
- Number of patients who will have bladder, urinary or bowel injuries during caesarean section(5 hours maximum)
- Number of patients with post-partum hemorrhage defined by blood loss more than 500mL(5 hours maximum)