The Effect of Trendelenburg Positioning on External Cephalic Version Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- External cephalic version success
研究概览
简要总结
Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. We will evaluate external cephalic version success and compare the 2 groups.
详细描述
This is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning.
The women that are eligible for participation will receive a thorough explanation and will sign informed consent.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women interested in having external cephalic version at a gestational age of 37+0/7 or more.
排除标准
- •Age 18 and under.
- •Women with a body mass index 35 or higher.
- •Women with a previous cesarean section.
- •Women with premature rupture of membranes.
- •Women with vaginal bleeding.
- •Women with a previously failed external cephalic version.
研究组 & 干预措施
Trendelenburg
Women positioned in the trendelenburg position during external cephalic version.
干预措施: Trendelenburg positioning (Other)
Control
Women positioned on their back during external cephalic version.
结局指标
主要结局
External cephalic version success
时间窗: Up to 10 minutes from the beginning of external cephalic version.
The rate of successful external cephalic version
次要结局
- Pain(Up to 2 hours from the beginning of external cephalic version.)
- Vaginal delivery(Up to 4 weeks from the beginning of external cephalic version.)
- Cesarean delivery(Up to 4 weeks from the beginning of external cephalic version.)
- Placental abruption(Up to 1 week from the beginning of external cephalic version.)
研究者
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus