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

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.

Study Overview

• Status: Recruiting
• Conditions: Water Birth
• Intervention / Treatment: Procedure: waterbirth

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Vitagliano JV Jean-Jacques, PhD; Phone Number: 03.20.69.42.80; Email: jjvitagliano@ch-tourcoing.fr
• Study Contact Backup: Name: Degrendel MD Maxime, MD; Phone Number: 03.20.69.42.80; Email: mdegrendel@ch-tourcoing.fr

Study Locations

• France
  • Hauts De France
    • Tourcoing, Hauts De France, France, 59200
      • Recruiting
      • Tourcoing hospital
      • Contact: Degrendel MD Maxime, MD; Phone Number: 03.20.69.42.80; Email: mdegrendel@ch-tourcoing.fr
      • Contact: Vitagliano JV Jean_Jacques, PhD; Phone Number: 03.20.69.42.80; Email: jvitagliano@ch-tourcoing.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients who have chosen to give birth physiologically at the Maternity unit will be offered the study during their maternity stay.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women with water births	Procedure: waterbirth; waterbirth: laboured for all or part of the first stage of labour and remained in the water for birth of newborn
women giving birth on land

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Principal Investigator: GOBERT JG julia, MD, Tourcoing hospital; Principal Investigator: GAILLARD JG Julie, Tourcoing hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22.01415.000084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No