Comparing midwifery care in alternative and traditional birth units in France
Accompagnement et Soins personnalisés Autour de la Naissance en filière Physiologique Versus filière Conventionnelle en France : Effets Sur la santé Psychique Des Couples et Sur la santé de la mère et de l'Enfant à l'âge de 2 Ans.
This study is testing whether giving birth in alternative midwifery units leads to better mental health for couples and healthier outcomes for mothers and children compared to traditional maternity units.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 748 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 3 sites (Eaubonne and 2 other locations) |
| Trial ID | NCT06630741 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effects of alternative midwifery units (AMUs) and traditional maternity units on the psychological health of couples and the health of mothers and children at the age of two. Couples who participated in the PhysioCare study will complete standardized questionnaires online two years after birth, assessing various aspects of maternal and child health. The study will also include semi-structured interviews to gather perceptions of care from women, partners, and professionals. The findings are expected to enhance understanding of perinatal care and improve practices in France.
Who should consider this trial
Good fit: Ideal candidates for this study are women who participated in the PhysioCare study and their partners, including first-time and non-first-time parents.
Not a fit: Patients who have withdrawn consent from the PhysioCare study or whose child has died since the last questionnaire will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal and child health outcomes and better support for families during childbirth.
How similar studies have performed: Other studies have shown success with midwifery-led care approaches, indicating potential benefits for maternal and child health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who participated in the PhysioCare study, as well as the already included first-time parents partners. * Non-first-time parent partners who received information about the PhysioCare study but did not participate. * Having been informed about the protocol and not having expressed opposition to participate in the PhysioCare study. Non-inclusion Criteria: * Participant who has withdrawn his/her consent to participate in the PhysioCare study * Participant excluded from the PhysioCare study * Death of the child since the last questionnaire was entered * Adults under legal protection (safeguard of justice, curatorship, guardianship) and persons deprived of liberty.
Where this trial is running
Eaubonne and 2 other locations
- Centre Hospitalier Simone Veil — Eaubonne, France (Recruiting)
- Clinique Mutualiste la Sagesse — Rennes, France (Recruiting)
- Rennes University Hospital — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Monperrus Marion — Rennes University Hospital
- Study coordinator: Monperrus Marion
- Email: Marion.MONPERRUS@chu-rennes.fr
- Phone: 299267326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.