DeliveryNCT06036277
Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women
An observational study of Delivery and Labor Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery, Labor Pain
- What is being tested?
- General data and Other data
- How many people
- 249 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnent women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.
Who may be able to join
- All women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.
Who cannot join
- Absence of physiological desire for childbirth.
- Medical indication for epidural anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Delivery, Labor Pain
- Being tested
- General data, Other data
- Keywords
- Water immersion, Waterbirth, Childbirth, Labor pain, Epidural anesthesia, Physiological delivery, Pregnant women, General medicine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General dataOther
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 dataOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Women who wish to give birth without epidural anesthesia and have benefited of water immersion during labor Receives: Other: General data; Other: Other data | |
| Control group | Women who wish to give birth without epidural anesthesia and have not benefited of water immersion during labor Receives: Other: General data; Other: Other data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of requests for epidural anesthesia by parturients
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Secondary outcomes (11)
Duration of the first stage of childbirth
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Duration of the second stage of childbirth
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Duration of the third stage of childbirth
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Number of instrumental extractions
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Number of caesareans
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Number and degree of perineal tear
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Use of episiotomy by the obstetrical team
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Arterial pH measured at the umbilical cord
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Number of neonatal resuscitation
Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliveryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine BARJAT, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036277
- Sponsor's protocol ID
- IRBN702023/CHUSTE
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06036277
- Acronym / sponsor ID
- IRBN702023/CHUSTE
- Conditions
- Delivery, Labor Pain
- Keywords
- Water immersion, Waterbirth, Childbirth, Labor pain, Epidural anesthesia, Physiological delivery, Pregnant women, General medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: General data, Other: Other dataWomen who wish to give birth without epidural anesthesia and have benefited of water immersion during labor |
| Control group | – | Other: General data, Other: Other dataWomen who wish to give birth without epidural anesthesia and have not benefited of water immersion during labor |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnent women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.
Key inclusion criteria (1 listed)
- All women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.
Key exclusion criteria (2 listed)
- Absence of physiological desire for childbirth.
- Medical indication for epidural anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General dataGeneral 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 | Control group, Experimental group |
| Other dataOther 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. | Other | Control group, Experimental group |
Primary outcome
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.
11 secondary outcomes
Duration of the first stage of childbirth
Time frame: Day 0
Duration of the second stage of childbirth
Time frame: Day 0
Duration of the third stage of childbirth
Time frame: Day 0
Number of instrumental extractions
Time frame: Day 0
Number of caesareans
Time frame: Day 0
Number and degree of perineal tear
Time frame: Day 0
Use of episiotomy by the obstetrical team
Time frame: Day 0
Estimated postpartum hemorrhagic volume and occurrence of postpartum hemorrhage
Time frame: Day 0
Apgar score (Appearance, Pulse, Grimace, Activity, Respiration) from 0 to 10 of the child at birth
Time frame: Day 0
Arterial pH measured at the umbilical cord
Time frame: Day 0
Number of neonatal resuscitation
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiphaine BARJAT, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delivery and Labor Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of requests for epidural anesthesia by parturients (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.