Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women

Labor Pain Clinical Trial

Official title:

Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women in Case of a Desire for Physiological Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036277
• Other study ID #: IRBN702023/CHUSTE
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Delivery
• Labor Pain

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