Clinical trial NCT06036277: Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delivery
Labor Pain
Keywords: Water immersion
Waterbirth
Childbirth
Labor pain
Epidural anesthesia
Physiological delivery
Pregnant women
General medicine
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 249
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of requests for epidural anesthesia by parturients
timeFrame: Day 0
Secondary outcomes:
measure: Duration of the first stage of childbirth
timeFrame: Day 0
measure: Duration of the second stage of childbirth
timeFrame: Day 0
measure: Duration of the third stage of childbirth
timeFrame: Day 0
measure: Number of instrumental extractions
timeFrame: Day 0
measure: Number of caesareans
timeFrame: Day 0
measure: Number and degree of perineal tear
timeFrame: Day 0
measure: Use of episiotomy by the obstetrical team
timeFrame: Day 0
measure: Estimated postpartum hemorrhagic volume and occurrence of postpartum hemorrhage
timeFrame: Day 0
measure: Apgar score (Appearance, Pulse, Grimace, Activity, Respiration) from 0 to 10 of the child at birth
timeFrame: Day 0
measure: Arterial pH measured at the umbilical cord
timeFrame: Day 0
measure: Number of neonatal resuscitation
timeFrame: Day 0
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Tiphaine BARJAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: