Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 4
- 主要终点
- Fetal head position
研究概览
简要总结
Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior.
Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.
详细描述
The prevalence of fetal occipitoposterior position during labor is 20%. Compared to anterior positions, they are known to be at higher risk of complications (cesarean section, instrumental delivery, severe perineal laceration).
Maternal posturing is used during labor to facilitate the rotation of the fetal head in anterior position. Asymmetrical lateral decubitus is used frequently, without having ever been evaluated.
Our study aims to evaluate the efficacy of this maternal posturing, through a randomized open trial.
We hypothesized that posturing women in asymmetrical lateral decubitus allows increasing frequency of anterior fetal position after 1 hour.
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
- •women older than 18 years
- •Gestational age ≥ 37SA,
- •Ruptured membranes,
- •single living fetus in cephalic presentation with an occipitoposterior position clinically diagnosed between 2 and 9 cm dilated and confirmed by ultrasound.
- •Affiliation to a social security scheme (beneficiary or assignee)
- •Signing the consent
排除标准
- •Fetal presentation other than posterior
- •Multiple pregnancy,
- •Breech presentation
- •History of previous cesarean section
- •Fetal death in utero, termination of pregnancy
- •Fetal intrauterine fetal growth restriction <5e percentile,
- •Fetal malformation,
- •Women younger than 18 years old,
- •Women do not understand French,
- •Women with psychiatric condition
研究组 & 干预措施
Asymmetrical Lateral Decubitus
Women in labor are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion
干预措施: Asymmetrical Lateral Decubitus (Other)
control
usual obstetrical care
干预措施: control (Other)
结局指标
主要结局
Fetal head position
时间窗: 1 hour
fetal head position one hour after randomization
次要结局
- Speed of cervical dilatation(during the first stage of labour)
- fetal head position(at diagnosis of full dilatation)
- Mode of delivery and perineal complications(at delivery)
- feasibility and acceptability of asymmetrical lateral decubitus(during and after labour)