NCT06036277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

August 21, 2023

Last Update Submit

September 12, 2023

Conditions

Keywords

Water immersionWaterbirthChildbirthLabor painEpidural anesthesiaPhysiological deliveryPregnant womenGeneral medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Duration of the first stage of childbirth

    Day 0

  • Duration of the second stage of childbirth

    Day 0

  • Duration of the third stage of childbirth

    Day 0

  • Number of instrumental extractions

    Day 0

  • Number of caesareans

    Day 0

  • +6 more secondary outcomes

Study Arms (2)

Experimental group

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

Other: General dataOther: Other data

Control group

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

Other: General dataOther: Other data

Interventions

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

Control groupExperimental group

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 groupExperimental group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnent women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.

You may qualify if:

  • All women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.

You may not qualify if:

  • Absence of physiological desire for childbirth.
  • Medical indication for epidural anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tiphaine BARJAT, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 13, 2023

Study Start

May 1, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations