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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06036277
Other study ID # IRBN702023/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date June 30, 2023

Study information

Verified date July 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 249
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
General data
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
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.

Locations

Country Name City State
France CHU Saint Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of requests for epidural anesthesia by parturients Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Duration of the first stage of childbirth Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Duration of the second stage of childbirth Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Duration of the third stage of childbirth Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Number of instrumental extractions Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Number of caesareans Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Number and degree of perineal tear Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Use of episiotomy by the obstetrical team Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Estimated postpartum hemorrhagic volume and occurrence of postpartum hemorrhage Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Apgar score (Appearance, Pulse, Grimace, Activity, Respiration) from 0 to 10 of the child at birth 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
Secondary Arterial pH measured at the umbilical cord Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
Secondary Number of neonatal resuscitation Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center. Day 0
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