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

NCT06441370 | Recruiting

• 1 other identifier: 22.01415.000084
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Water Birth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dimension of the quality and experience of childbirth within 3 days of delivery

  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

  This questionnaire is to be completed within 2 months of delivery.

• Anxiety and depression at 2 months of delivery.

  This questionnaire is to be completed within 2 months of delivery.

Study Arms (2)

women with water births

Procedure: waterbirth

women giving birth on land

Interventions

waterbirth PROCEDURE

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

women with water births

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tourcoing Hospital: lead

Study Sites (1)

Tourcoing Hospital

Tourcoing, Hauts-de-France, 59200, France

RECRUITING

MeSH Terms

Interventions

Natural Childbirth

Intervention Hierarchy (Ancestors)

Parturition; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• GOBERT JG julia, MD

  Tourcoing Hospital

  PRINCIPAL INVESTIGATOR

• GAILLARD JG Julie

  Tourcoing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitagliano JV Jean-Jacques, PhD

CONTACT

03.20.69.42.80; jjvitagliano@ch-tourcoing.fr

Degrendel MD Maxime, MD

CONTACT

03.20.69.42.80; mdegrendel@ch-tourcoing.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)