Water BirthAQUAMODANCT06441370
Patient Satisfaction During Physiological Water or Land Birth: a Prospective Study in an French Tertiary Maternity Unit.
An observational study of Water Birth, run by Tourcoing Hospital at 1 site in France.
Trial summary
A study will be carried out to compare the level of satisfaction and psychological state of women who give birth in water with those who give birth out of water. The aim is to demonstrate the benefits of water birth and justify its place in the healthcare offering. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Water Birth
- What is being tested?
- waterbirth
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 1 Jun 2026
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who have chosen to give birth physiologically at the Maternity unit will be offered the study during their maternity stay.
Who may be able to join
- Major patient
- Social security beneficiary
- Presence of a companion
- Delivery greater than or equal to 37 weeks of amenorhoea
- Spontaneous labor
- Cephalic presentation
- Physiological delivery by woman's choice according to 2017 HAS criteria (French recommendations)
Who cannot join
- Patient under court protection
- Patient under guardianship or curatorship
- Placement of an epidural
- Language barrier
- Unexpected delivery (unwanted by the woman)
- Scarred uterus
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- Meconium fluid
- Maternal pathologies: epilepsy, MS (depending on neurological opinion), diabetes (types 1 and 2), herpes infection, HIV, HBV, HCV
- History of delivery hemorrhage > 1L
- History of shoulder dystocia/clavicle fracture
- Metrorrhagia
- Administration of nalbuphine within 2 hours of birth.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Tourcoing Hospital
Tourcoing, Hauts-de-France, 59200
Vitagliano JV Jean_Jacques, PhD, 03.20.69.42.80, jvitagliano@ch-tourcoing.fr
Degrendel MD Maxime, MD, 03.20.69.42.80, mdegrendel@ch-tourcoing.fr
About this study
Official title: Patient Satisfaction With Physiological Childbirth in Water or on Land a Prospective Study at the Tourcoing Hospital Maternity Unit
A study will be carried out to compare the level of satisfaction and psychological state of women who give birth in water with those who give birth out of water.
The aim is to demonstrate the benefits of water birth and justify its place in the healthcare offering.
- Conditions
- Water Birth
- Being tested
- waterbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterbirthProcedure or surgery
waterbirth: laboured for all or part of the first stage of labour and remained in the water for birth of newborn
| Study group | Role | What they receive |
|---|---|---|
| women with water births | Not described Receives: Procedure: waterbirth | |
| women giving birth on land | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived control over childbirth
The "perception of control over childbirth" dimension of the QEVA (Quality and Experience of Childbirth), a long version with a total of 6 dimensions. The score associated with the "perception of control over childbirth" dimension is obtained by averaging responses to items 8, 10, 11, 12, 14 and 18 of the questionnaire. The response to each of these items is coded on a Likert scale from 1 to 4, with a high value corresponding to poor control.
Measured: This questionnaire will be achieved by participating women within 3 days postpartum, before discharge from the maternity ward.
Secondary outcomes (3)
Dimension of the quality and experience of childbirth within 3 days of delivery
The scores associated with the 5 other dimensions of the QEVA questionnaire:
- Expectations, defined by items 9, 15 and 20;
- Sensory experience, defined by items 3 and 16;
- Relationship with caregivers, defined by items 5, 6, 7 and 13;
- Emotions, defined by items 1, 2, 4, 21, 22, 23 and 24;
- First moments with baby, defined by items 17, 18 and 19; Answers to the questions are coded on Likert scales from 1 to 4. Each score is calculated by averaging the responses to the questions in the dimension in question.
Measured: This questionnaire is to be completed within 3 days of delivery, before discharge from the maternity hospital.
Dimension of the quality and experience of childbirth within 2 months of delivery
The scores associated with the 5 other dimensions of the QEVA questionnaire:
- Expectations, defined by items 9, 15 and 20;
- Sensory experience, defined by items 3 and 16;
- Relationship with caregivers, defined by items 5, 6, 7 and 13;
- Emotions, defined by items 1, 2, 4, 21, 22, 23 and 24;
- First moments with baby, defined by items 17, 18 and 19; Answers to the questions are coded on Likert scales from 1 to 4. Each score is calculated by averaging the responses to the questions in the dimension in question.
Measured: This questionnaire is to be completed within 2 months of delivery.
Anxiety and depression at 2 months of delivery.
The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess anxiety and depression and depression at 2 months postpartum in order to screen for possible postpartum depression.
Measured: This questionnaire is to be completed within 2 months of delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water BirthStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GOBERT JG julia, MD, Principal investigator, Tourcoing HospitalGAILLARD JG Julie, Principal investigator, Tourcoing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441370
- Sponsor's protocol ID
- 22.01415.000084
- Acronym
- AQUAMODA
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Physiological Childbirth in Water or on Land a Prospective Study at the Tourcoing Hospital Maternity Unit
- ClinicalTrials.gov ID
- NCT06441370
- Acronym / sponsor ID
- AQUAMODA / 22.01415.000084
- Conditions
- Water Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 4 Jun 2024 (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.
A study will be carried out to compare the level of satisfaction and psychological state of women who give birth in water with those who give birth out of water.
The aim is to demonstrate the benefits of water birth and justify its place in the healthcare offering.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with water births | – | Procedure: waterbirth |
| women giving birth on land | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have chosen to give birth physiologically at the Maternity unit will be offered the study during their maternity stay.
Key inclusion criteria (7 listed)
- Major patient
- Social security beneficiary
- Presence of a companion
- Delivery greater than or equal to 37 weeks of amenorhoea
- Spontaneous labor
Key exclusion criteria (12 listed)
- Patient under court protection
- Patient under guardianship or curatorship
- Placement of an epidural
- Language barrier
- Unexpected delivery (unwanted by the woman)
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 |
|---|---|---|
| waterbirthwaterbirth: laboured for all or part of the first stage of labour and remained in the water for birth of newborn | Procedure or surgery | women with water births |
Primary outcome
Perceived control over childbirth
Time frame: This questionnaire will be achieved by participating women within 3 days postpartum, before discharge from the maternity ward.
The "perception of control over childbirth" dimension of the QEVA (Quality and Experience of Childbirth), a long version with a total of 6 dimensions. The score associated with the "perception of control over childbirth" dimension is obtained by averaging responses to items 8, 10, 11, 12, 14 and 18 of the questionnaire. The response to each of these items is coded on a Likert scale from 1 to 4, with a high value corresponding to poor control.
3 secondary outcomes
Dimension of the quality and experience of childbirth within 3 days of delivery
Time frame: This questionnaire is to be completed within 3 days of delivery, before discharge from the maternity hospital.
Dimension of the quality and experience of childbirth within 2 months of delivery
Time frame: This questionnaire is to be completed within 2 months of delivery.
Anxiety and depression at 2 months of delivery.
Time frame: This questionnaire is to be completed within 2 months of delivery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- 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.
GOBERT JG julia, MD principal investigator
Tourcoing Hospital
GAILLARD JG Julie principal investigator
Tourcoing Hospital
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 Water Birth, run by Tourcoing Hospital 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitagliano JV Jean-Jacques, PhD (03.20.69.42.80, jjvitagliano@ch-tourcoing.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived control over childbirth (time frame: This questionnaire will be achieved by participating women within 3 days postpartum, before discharge from the maternity ward.). 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 4 Jun 2024.