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Completed

NCT Number: NCT06036277

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

CHU Saint Etienne

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General data

Other

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

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.

Primary outcomes

  1. Number of requests for epidural anesthesia by parturients

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

Secondary outcomes

  1. Duration of the first stage of childbirth

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  2. Duration of the second stage of childbirth

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  3. Duration of the third stage of childbirth

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  4. Number of instrumental extractions

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  5. Number of caesareans

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  6. Number and degree of perineal tear

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  7. Use of episiotomy by the obstetrical team

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  8. Estimated postpartum hemorrhagic volume and occurrence of postpartum hemorrhage

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  9. Apgar score (Appearance, Pulse, Grimace, Activity, Respiration) from 0 to 10 of the child at birth

    Time frame: 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.

  10. Arterial pH measured at the umbilical cord

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

  11. Number of neonatal resuscitation

    Time frame: Day 0

    Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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