NCT06630741: PhysioCareTwo

Support and Personalized Care in Alternative Midwifery Birth Units Versus Traditional Units in France: Effects on the Psychological Health of Couples and on the Health of the Mother and Child at the Age of 2 Years.

Recruiting now Last updated 27 February 2025

What this trial tests

trial testing alternative midwifery units (AMU) in To Compare 2 Models of Midwifery Care in Maternity Care in 748 participants. Currently enrolling.

Timeline

9 October 2024

Primary endpoint
9 July 2025

9 July 2025

Quick facts

Lead sponsor	Rennes University Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	748
Start date	9 October 2024
Primary completion	9 July 2025
Estimated completion	9 July 2025
Sites	3 locations across France

Drugs / interventions tested

• alternative midwifery units (AMU)

Conditions studied

• To Compare 2 Models of Midwifery Care in Maternity Care — all drugs for To Compare 2 Models of Midwifery Care in Maternity Care →

Sponsor

Rennes University Hospital

Who can join

18 and older, any sex, with To Compare 2 Models of Midwifery Care in Maternity Care. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Majority of pregnancies and childbirths in France occur without complication. While the impact of care failure on maternal and neonatal morbi-mortality is now well- established, the literature reveals that an overmedicalization of pregnancy and childbirth care is not associated with improved maternal and child health outcomes. Conversely, it could have detrimental effects, in addition to representing unnecessary healthcare expenditure. Recent national and international guidelines on the management of normal childbirth (full-term birth without complications) aim to facilitate physiological labor and minimize unnecessary medical interventions, especially for women at low obstetrical risk (without relevant medical history and a normal pregnancy). Creating Midwifery birth units to support these pregnant women aligns with these recommendations.

In France, four innovative alternative midwifery units (AMU), devoted to management of low-risk pregnancy and natural or physiological childbirth (i.e., without any human intervention, including epidural anesthesia), have been developed within hospital structures during the recent years. The AMU, unlike freestanding midwifery units, enable a non-medicalized childbirth within a maternity hospital, with immediate care available for pregnant women and/or their child in cases of life-threatening emergencies (AMU co-exist in the same building on the same site as a hospital or host obstetric unit within conventional obstetric units, but with dedicated and separate spaces). Personalized follow-up, starting from the early stages of pregnancy, and birth and parenthood preparation classes are provided by a designated midwife and are offered to couples wishing to without any fee exceeding the standard medical charges. Delivery takes place in a birthing room with specific and not medicalized equipment.

Available studies in France and abroad suggest that home births or birth in freestanding midwifery units do not increase perinatal morbidity. They may enhance the childbirth experience, positively influencing the establishment of the mother-child bond and the psychological well-being of parents in the PostPartum (PP) period, which in turn can impact the short- and long-term child development. Professional support provided by midwives is crucial throughout this period (pregnancy, delivery and PP), benefiting both the pregnant woman and the future father. A positive birth experience can, therefore, strengthen self-confidence and be decisive for family unit cohesion. In addition, two recent studies have shown that a traumatic birth experience is strongly correlated with PP depression in both parents and difficulties in the mother-child bond. This lead to the conclusion that personalised and special support offer to couples during this experience of parenthood, which could involve the development of midwives-led birth units. A recent meta-analysis also encourages further research that would provide insights into the long-term effects of global perinatal care, particularly on mother-child interaction and PP depression.

The PhysioCare study (end in July 2023) aimed to investigate the impact of such care on women's psychological health during the first six weeks following childbirth. However, no study has examined the long-term effects on mental health beyond the immediate PP period. PhysioCareTwo will serve as the continuation of the PhysioCare research project (Principal Investigator: R. GARLANTEZEC). This research has been conducted in three French centers, with follow-up assessments extending up to six weeks PP. Inclusion for this previous project began on 01/09/2022 and ended on 29/04/2023. This is the first French study to address this issue and to evaluate care units such as AMU, with the participation of 3 out of 4 maternity units in France offering this kind of care.

The coexistence of standard obstetric units (SOU) and AMU within the same maternity unit provides an opportunity to assess the impact of this innovative care approach. PhysioCareTwo will enable the ongoing followed up of couples beyond the initial 6 weeks PP, with an assessment of the mental well-being of both mothers and co-parents two years after childbirth.

Providing AMU care to women with low obstetrical risk, as compared to standard birth care units, could enhance the psychological well-being of parents in both the short and long term.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.