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

Healthy Clinical Trial

— IMMERSION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409953
• Other study ID #: 5979
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: October 5, 2017
• Start date: April 15, 2015
• Est. completion date: May 13, 2016

Study information

• Verified date: October 2017
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 13, 2016
• Est. primary completion date: May 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Lying in a bath during 2 hours

• Lying in a bed during 2 hours

Locations

Country	Name	City	State
France	Service d'Anesthésie - Réanimation Chirurgicale de Hautepierre	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diuresis (urine volume in milliliters)		120 minutes