Skip to main content
Clinical Trials/NCT02409953
NCT02409953CompletedNot Applicable

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

University Hospital, Strasbourg, France2 sites in 1 country40 target enrollmentStarted: April 15, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
diuresis (urine volume in milliliters)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Bath

Experimental

Intervention: Lying in a bath during 2 hours (Other)

Bed

Placebo Comparator

Intervention: Lying in a bed during 2 hours (Other)

Outcomes

Primary Outcomes

diuresis (urine volume in milliliters)

Time Frame: 120 minutes

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials