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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lying in a bath during 2 hours
Lying in a bed during 2 hours
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy female volunteers aged 18 to 45 years

Exclusion Criteria:

  • 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

Sites / Locations

  • Service d'Anesthésie - Réanimation Chirurgicale de Hautepierre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bath

Bed

Arm Description

Outcomes

Primary Outcome Measures

diuresis (urine volume in milliliters)

Secondary Outcome Measures

Full Information

First Posted
March 24, 2015
Last Updated
October 5, 2017
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02409953
Brief Title
Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women
Acronym
IMMERSION
Official Title
Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 15, 2015 (undefined)
Primary Completion Date
May 13, 2016 (Actual)
Study Completion Date
May 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bath
Arm Type
Experimental
Arm Title
Bed
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Lying in a bath during 2 hours
Intervention Type
Other
Intervention Name(s)
Lying in a bed during 2 hours
Primary Outcome Measure Information:
Title
diuresis (urine volume in milliliters)
Time Frame
120 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy female volunteers aged 18 to 45 years Exclusion Criteria: 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
Facility Information:
Facility Name
Service d'Anesthésie - Réanimation Chirurgicale de Hautepierre
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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