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NCT02409953: IMMERSION
Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women
NA trial testing Lying in a bath during 2 hours in Healthy in 40 participants. Completed in 13 May 2016.
13 May 2016
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 15 April 2015 |
| Primary completion | 13 May 2016 |
| Estimated completion | 13 May 2016 |
| Sites | 1 location across France |
Drugs / interventions tested
- Lying in a bath during 2 hours
- Lying in a bed during 2 hours
Conditions studied
- Healthy — all drugs for Healthy →
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:
- PubMed search for NCT02409953
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02409953 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Strasbourg, France
- Last refreshed: 9 October 2017
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