Patient Satisfaction During Physiological Water or Land Birth: a Prospective Study in an French Tertiary Maternity Unit.

Water Birth Clinical Trial

— AQUAMODA  

Official title:

Patient Satisfaction With Physiological Childbirth in Water or on Land a Prospective Study at the Tourcoing Hospital Maternity Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06441370
• Other study ID #: 22.01415.000084
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Tourcoing Hospital
• Contact: Vitagliano JV Jean-Jacques, PhD
• Phone: 03.20.69.42.80
• Email: jjvitagliano[@]ch-tourcoing.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Patient under court protection
• Patient under guardianship or curatorship
• Placement of an epidural
• Language barrier
• Unexpected delivery (unwanted by the woman)
• Scarred uterus
• 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.

Related Conditions & MeSH terms

• Water Birth

Intervention

Procedure:
• waterbirth
waterbirth: laboured for all or part of the first stage of labour and remained in the water for birth of newborn

Locations

Country	Name	City	State
France	Tourcoing Hospital	Tourcoing	Hauts De France

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This questionnaire will be achieved by participating women within 3 days postpartum, before discharge from the maternity ward.
Secondary	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.	This questionnaire is to be completed within 3 days of delivery, before discharge from the maternity hospital.
Secondary	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.	This questionnaire is to be completed within 2 months of delivery.
Secondary	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.	This questionnaire is to be completed within 2 months of delivery.