Last reviewed · How we verify

NCT02409953: IMMERSION

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

Completed NA Last updated 9 October 2017
What this trial tests

NA trial testing Lying in a bath during 2 hours in Healthy in 40 participants. Completed in 13 May 2016.

Timeline
15 April 2015
Primary endpoint
13 May 2016
13 May 2016

Quick facts

Lead sponsorUniversity Hospital, Strasbourg, France
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date15 April 2015
Primary completion13 May 2016
Estimated completion13 May 2016
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Strasbourg, France

Who can join

Adults 18 to 45, female only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other University Hospital, Strasbourg, France trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02409953.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing