Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 119
- 试验地点
- 4
- 主要终点
- cephalic presentation at birth
研究概览
简要总结
The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.Patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. The randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; The efficacy's evaluation is based on rate of cephalic presentation at birth.Success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied.
Prospective interventional randomized sequential comparative multicentric study. A maximum of 240 patients will be included (120 in each group). As the study is sequential it will be over as soon as a significative difference is shown.
详细描述
The purpose of the study is to evaluate the effect of transabdominal amnioinfusion before a second external cephalic version after initial failure. In case of success it could be an alternative to cesarian section. Without any other technique the foetus is in cephalic presentation after a first external cephalic version in 50%.
Patients with a single fetus, at term, in breech presentation are proposed to participate. The randomization is done at the inclusion and determines whether the patient is included in the group with amnioinfusion before second cephalic version or usual second cephalic version only. The only difference between the two groups is the realisation of an amnioinfusion, the cephalic version's technique is the same.
Efficacy's evaluation is based on rate of cephalic presentation at birth. Success rate of cephalic version, rates of cesarian section, maternal and fetal morbidity in the two groups, time between second cephalic version and birth will be studied.
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
- •single fetal pregnancy
- •breech presentation
- •initial failure of external cephalic version
- •structurally normal foetus
排除标准
- •polyhydramnios
- •anhydramnios
- •abnormality of the fetal heart rhythm
- •uterine congenital malformation
- •cesarian section for a previous birth
- •unability to understand study
研究组 & 干预措施
A
Transabdominal amnioinfusion performed before external cephalic version
干预措施: transabdominal amnioinfusion (Procedure)
V
Without transabdominal amnioinfusion
结局指标
主要结局
cephalic presentation at birth
时间窗: at birth
次要结局
未报告次要终点