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临床试验/NCT04544488
NCT04544488Unknown不适用

Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年12月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
1
主要终点
characteristics of the pushing efforts assessed by measuring intra bladder pressur

研究概览

简要总结

Severe complications of childbirth are common. Many factors have been studied to assess their imputability in the occurrence of perineal tears. While women subjectively have different push profiles in terms of intensity, frequency and duration of each push effort, no study has evaluated this variability in a relevant, simple and reproducible way. Through this work, it is expected to establish a qualitative evaluation of the expulsive efforts during childbirth in term nulliparous women by measuring the intra bladder pressure which testifies of the pressure exerted on the perineal tissues due to maternal pushing efforts

详细描述

Scientific context:

It is clearly observed in clinical practice that there seems to be significant variability in the characteristics of the expulsive phase from one woman to another without this being clearly described to date. During the same expulsive phase, the number, intensity and duration of each push can be very different from one woman to another.

Considering that during expulsive efforts, the fetal head exerts pressure on the perineal tissues , the repetition of these compressions, moreover if they are prolonged or brought closer together could generate muscular lesions by hyper extension of the fibers, by microtrauma or by tissue hypoxia. These variations in the characteristics of expulsive efforts could thus modify the perineal risk for women.

More than the expulsive efforts evaluated by the recording of intra uterine pressures which has already been described, it is the evaluation of the mechanical stresses transmitted to the perineum secondary to the pushing efforts that we would like to record by the installation of a sensor pressure connected to the woman's bladder catheter.

Investigations During the second phase of labor, at 8 cm dilation, after information and obtaining free and informed consent, women will be included by one of the MD investigators.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

characteristics of the pushing efforts assessed by measuring intra bladder pressur

时间窗: Day of inclusion

At inclusion it will be collect the characteristics of the pushing efforts: the intensity, the duration (total and of each effort) and the frequency of the expulsive efforts, which will be described in terms of mean and standard deviation.

次要结局

  • Perineal tear(Day of inclusion, immediately after delivery)
  • Clinical pelvic organ mobility(12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion)
  • Ultrasound pelvic organ mobility(12 to 16 weeks after inclusion then 26 to 30 weeks after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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