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临床试验/NCT01911481
NCT01911481已完成不适用

Maternal Oral Hydration and External Cephalic Version: a Single Blind Randomised Controlled Trial

University of Milano Bicocca2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2011年10月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
2
主要终点
Number of participants with external cephalic version successful after maternal oral hydration
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigators are carrying out a study of 164 pregnant women, with breech presentation at term who will undergo to external cephalic version. The investigators' goal is to know if oral maternal hydration can increase the successful of external cephalic version

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Care Provider)

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 gestation
  • •breech presentation
  • •from 37 to 41,5 weeks
  • •without pregnancy complications
  • •fetus adequate for gestational age
  • •without fetal malformations
  • •intact membranes
  • •amniotic fluid index between 7 and 24 cm
  • •placenta properly inserted

排除标准

  • •age less than 18 years
  • •maternal disease at risk of fluid overload (cardiac disease, renal impairment, moderate or severe preeclampsia or hypertension and diabetes)
  • •contraindications for vaginal birth
  • •vaginal blood loss
  • •uterine contractions

结局指标

主要结局

Number of participants with external cephalic version successful after maternal oral hydration

时间窗: The primary outcome will be assessed by ultrasound examination, 5 minutes after ending of the external cephalic version

The primary outcome of the study is to evaluate the successful rate of external cephalic version, after oral intake of two litres of water

次要结局

  • type of birth(at birth)
  • amniotic fluid volume(1 hour after the end of oral maternal hydration (2 litres))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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