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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT06036277

Collaborator

(none)

249

Enrollment

Location

Actual Duration (Months)

126.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Delivery Labor Pain	Other: General data Other: Other data

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 Design

Study Type:

Observational

Actual Enrollment :

249 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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

Actual Study Start Date :

May 1, 2023

Actual Primary Completion Date :

Jun 30, 2023

Actual Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental group Women who wish to give birth without epidural anesthesia and have benefited of water immersion during labor	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: 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.
Control group Women who wish to give birth without epidural anesthesia and have not benefited of water immersion during labor	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: 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.

Arm

Intervention/Treatment

Experimental group

Women who wish to give birth without epidural anesthesia and have benefited of water immersion during labor

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: 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.

Control group

Women who wish to give birth without epidural anesthesia and have not benefited of water immersion during labor

Other: General data

Other: Other data

Outcome Measures

Primary Outcome Measures

Number of requests for epidural anesthesia by parturients [Day 0]
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

Secondary Outcome Measures

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