- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06036277
Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women
September 12, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women in Case of a Desire for Physiological Delivery
Women are showing a growing interest in less medicalized childbirth.
According to the french 2021 perinatal survey, 52.2% of women want to limit medical procedures and 38.2% of women want childbirth without epidural anesthesia.
Between 77 and 82% of deliveries nevertheless lead to an epidural anesthesia.
The painful feeling seems to be the main motivation for using this mode of anesthesia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the scientific literature, few data from clinical studies focus on the effects of immersion in water during childbirth.
The analgesic effects of immersion in water to lessen the painful experience are yet to be proven.
The opening of a physiological delivery room with a bathtub at the Saint-Etienne University Hospital since October 2020 provides data that has not been exploited yet and could make possible to answer the question of the analgesic effects of immersion in water during labour.
The difficulties of analysis and the subjectivity of the painful feeling led us to consider the request of epidural anesthesia as the main analysis criterion.
Study Type
Observational
Enrollment (Actual)
249
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Étienne, France, 42000
- CHU Saint Etienne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Pregnent women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.
Description
Inclusion Criteria:
- All women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.
Exclusion Criteria:
- Absence of physiological desire for childbirth.
- Medical indication for epidural anesthesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental group
Women who wish to give birth without epidural anesthesia and have benefited of water immersion during labor
|
General data will be collected to ensure that both groups are comparable : maternal age, maternal BMI, gestational age, parity, number of children in current pregnancy, history of caesarian section, newborn child weight
Other data collected will be used to estimate primary and secondary outcomes : request for an epidural anesthesia by the parturient, medical indication for peridural anesthesia, duration of childbirth, delivery methods, occurrence of maternal or neonatal complications.
|
|
Control group
Women who wish to give birth without epidural anesthesia and have not benefited of water immersion during labor
|
General data will be collected to ensure that both groups are comparable : maternal age, maternal BMI, gestational age, parity, number of children in current pregnancy, history of caesarian section, newborn child weight
Other data collected will be used to estimate primary and secondary outcomes : request for an epidural anesthesia by the parturient, medical indication for peridural anesthesia, duration of childbirth, delivery methods, occurrence of maternal or neonatal complications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of requests for epidural anesthesia by parturients
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of the first stage of childbirth
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Duration of the second stage of childbirth
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Duration of the third stage of childbirth
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Number of instrumental extractions
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Number of caesareans
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Number and degree of perineal tear
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Use of episiotomy by the obstetrical team
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Estimated postpartum hemorrhagic volume and occurrence of postpartum hemorrhage
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Apgar score (Appearance, Pulse, Grimace, Activity, Respiration) from 0 to 10 of the child at birth
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. At 5 minutes a score of 7 to 10 is considered normal; a score of 4 to 6 is intermediate and a score of 0 to 3 is low. |
Day 0
|
|
Arterial pH measured at the umbilical cord
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
|
Number of neonatal resuscitation
Time Frame: Day 0
|
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tiphaine BARJAT, MD PhD, CHU Saint Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
August 21, 2023
First Submitted That Met QC Criteria
September 12, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBN702023/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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