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临床试验/NCT05020340
NCT05020340尚未招募不适用

Reattempt of External Cephalic Version After Regional Anaesthesia Immediately Before a Caesarean Delivery - a Randomized Controlled Trial

The University of Hong Kong0 个研究点目标入组 42 人开始时间: 2021年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
Vaginal birth

研究概览

简要总结

Fetal malpresentation at term affects around 5% of pregnancy and breech presentation is the most common type of malpresentation. It is a common indication for a Caesarean delivery. External cephalic version (ECV) refers to turning the fetus manually and aims to increase the success of vaginal birth by reducing the need for Caesarean section.

详细描述

Several factors affect the chance of a successful ECV which include multiparity, use of tocolytic and regional anaesthesia during the procedure. Anticipating or not tolerating a painful procedure is another factor that affects the willingness to and success of ECV.

ECV can be reattempted under regional anaesthesia immediately just before the Caesarean section to increase the vaginal birth rate in women who have failed an ECV. Therefore, the aim of this study is to evaluate whether this approach could increase the rate of vaginal birth and reduce the non-cephalic presentation at labour and Caesarean section rate.

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 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All women age ≥ 18 years old
  • Singleton pregnancy
  • Malpresentation
  • Have failed an ECV
  • Pregnant ≥ 37 weeks of gestation

排除标准

  • Condition requiring emergency delivery
  • Other indication for Caesarean section
  • History of antepartum haemorrhage in the past 7 days
  • Oligohydraminos with amniotic fluid index <5cm
  • Intrauterine growth restriction with abnormal fetal Doppler or cardiotocography
  • Rhesus isoimmunization
  • Rupture of membranes
  • Gross fetal anomaly
  • Major uterine anomaly
  • Contraindication or refusal to regional anaesthesia
  • Spontaneous cephalic version on the day of scheduled Caesarean section

结局指标

主要结局

Vaginal birth

时间窗: Delivery

Vaginal birth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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