Clinical trial NCT06630741: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: To Compare 2 Models of Midwifery Care in Maternity Care
Keywords: Midwife-led care
midwifery birth units
physiologic birth; continuity of patient care
humanized care
post-traumatic stress disorders
postpartum depression
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who gave birth in a maternity hospital involved in the study, with a low-risk pregnancy and their co-parent

Brief summary: 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.

Detailed description: Method and Material:

Couples included in the prospective multi-center observational PhysioCare study (3 centers ; exposed/unexposed,1:2 ratio (1 woman in AMU for 2 in SOU), matched by center and parity) will be invited to complete standardized questionnaires online 2 years after birth: City Birth Trauma Scale, Edinburgh Postnatal Depression Scale, generic SF-12 questionnaire, Mother-to-Infant Bonding scale, Questionnaire d'Auto-Evaluation de la Compétence Educative Parentale, Multidimensional Scale of Perceived Social Support, Child Development Inventory (short version), data on breastfeeding and health. Estimated sample size at 2 years (with 70% of respondents): 420 women; 328 coparents. Semi-structured interviews to assess women's, partners' and professionals' perceptions of care will be conducted on a sample of couples. Multivariate intention-to-treat statistical analyses (linear/logistic regression with propensity score, IPTW) will be performed.

Findings expected :

PhysioCareTwo study has the potential to produce significant results that improve maternal and child health, strengthen medical practices, and promote family well-being. These spin-offs can have a positive impact in the short, medium and long term in the perinatal field.

Conclusion :

To generate concrete knowledge for the benefit of parents and their children, improve perinatal care in France, and promote these care approach.

Eligibility 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.

Primary outcomes:
measure: To investigate the impact of providing care to women in AMU, compared to women receiving standard care in SOU, on the level of post-traumatic stress disorder following childbirth for the mother, two years after birth
timeFrame: Two years after delivery
Secondary outcomes:
measure: Compare between AMU and SOU, 2 years after delivery: The level of post-traumatic stress disorders following childbirth for the co-parent
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery:The risk of depression for mothers and co-parents over the 2 year period
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery:. Mother's and co-parent's general quality-of-life
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: The development of the mother-child bond in mothers
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: Parenting Sense of Competence for the mother and co-parent
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: Global infant development at age 2
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: Perceived social support for mother and co-parent
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: h. Breastfeeeding duration
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: Mother indicators for the first two years of life
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery:The evolution of scores on Post Partum (PP) depression questionnaires completed in the PhysioCare study (PP depression and development of the mother-child bond) from birth to 2 years
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: representations of care by the mother and co-parent, birth experience, establishment of the mother child bond and quality of life 2 years after birth
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: The evolution of mother-child bonding development scores in the PhysioCare study from birth to 2 years
timeFrame: Two years after delivery
measure: Compare between AMU and SOU, 2 years after delivery: Child indicators for the first two years of life
timeFrame: Two years after delivery
Other outcomes:
Locations:
city: Eaubonne
country: France
facility: Centre Hospitalier Simone Veil
city: Rennes
country: France
facility: Clinique Mutualiste la Sagesse
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Monperrus Marion
role: PRINCIPAL_INVESTIGATOR
References: