ClinicalTrials.gg
CompletedNCT02409953IMMERSIONUpdated Oct 9, 2017

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

An interventional study of Lying in a bath during 2 hours and Lying in a bed during 2 hours in Healthy, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-09.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • volunteers
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy female volunteers aged 18 to 45 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Bath

    Other: Lying in a bath during 2 hours

  • Placebo comparator
    Bed

    Other: Lying in a bed during 2 hours

Interventions

  • OtherLying in a bath during 2 hours
  • OtherLying in a bed during 2 hours
06

What researchers measure

Primary outcomes

  1. diuresis (urine volume in milliliters)

    Time frame: 120 minutes

07

Study locations

1 site
  • Service d'Anesthésie - Réanimation Chirurgicale de Hautepierre
    Strasbourg, Alsace 67098, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2015, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2015
First posted
Apr 7, 2015
Start
Apr 15, 2015
Primary completionActual
May 13, 2016
CompletionActual
May 13, 2016
Last update
Oct 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02409953
Responsible party
Sponsor
First posted
Apr 7, 2015
Start date
Apr 15, 2015
Primary completion
May 13, 2016
Completion
May 13, 2016
Last update
Oct 9, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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