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

NCT02409953 | Completed

• 1 other identifier: 5979
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• diuresis (urine volume in milliliters)

  120 minutes

Study Arms (2)

Bath

EXPERIMENTAL

Other: Lying in a bath during 2 hours

Bed

PLACEBO COMPARATOR

Other: Lying in a bed during 2 hours

Interventions

Lying in a bath during 2 hours OTHER

Bath

Lying in a bed during 2 hours OTHER

Bed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female volunteers aged 18 to 45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'Anesthésie - Réanimation Chirurgicale de Hautepierre

Strasbourg, Alsace, 67098, France

Location

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 7, 2015
• Study Start: April 15, 2015
• Primary Completion: May 13, 2016
• Study Completion: May 13, 2016
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)