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临床试验/NCT02409953
NCT02409953已完成不适用

Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
diuresis (urine volume in milliliters)

研究概览

简要总结

Like in the full immersion, studied in the context of diving, immersion in water causes a cascade of events with hemodynamic and hormonal consequences.

First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60 minutes later, hypovolemia by stimulating diuresis.

Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.

However, when the labor progresses, the dilatation bath is no longer sufficient and epidural analgesia remains the only effective method to control pain.

Used before the realization of an epidural analgesia, dilatation bath could affect blood volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked to the installation of sensory block of the epidural analgesia in the parturient (severe prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal distress).

Before beginning a study in pregnant women, it seems essential to study the hemodynamic consequences of the dilatation bath in a comparable population of volunteers healthy young women and out of the obstetrical context.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy female volunteers aged 18 to 45 years

排除标准

  • pregnancy
  • menopause (confirmed for at least 12 weeks)
  • breastfeeding
  • Proteinuria> 2 cross on the dipstick
  • Glycosuria > 2 cross on the dipstick
  • subject with no empty stomach for at least 8 hours
  • Taking medication in the week before the test affecting diuresis, production of antidiuretic hormone or on the cardiovascular system: paracetamol, nonsteroidal anti-inflammatory Alcohol intake the day before the tes

研究组 & 干预措施

Bath

Experimental

干预措施: Lying in a bath during 2 hours (Other)

Bed

Placebo Comparator

干预措施: Lying in a bed during 2 hours (Other)

结局指标

主要结局

diuresis (urine volume in milliliters)

时间窗: 120 minutes

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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