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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

748 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-09

Study Completion Date

2025-07-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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To Compare 2 Models of Midwifery Care in Maternity Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients in alternative midwifery units (AMU)

In alternative midwifery birth units: personalized follow-up with a midwife from the beginning of pregnancy, birth and parenthood preparation classes and delivery (birth room)

alternative midwifery units (AMU)

Intervention Type OTHER

Alternative midwifery birth units are a new model of care in France in which the midwife is the primary health care professional caring for low-risk pregnant women, as opposed to those cared for by an obstetrician-led medical team. Accordingly, alternative midwifery birth units also provide a space within which midwives can practice to their fullest potential with more professional autonomy than in a traditional obstetric setting. These birth units emphasizes care that promotes normal physiologic pregnancy and labor and supports the natural ability of women to experience birth with minimum or no routine intervention.

Alternative midwifery birth units named Filière physiologique co-exist in the same building on the same site as a hospital or host obstetric unit. In the event a laboring women needs comprehensive emergency obstetric care, she can be transferred immediatly in a conventionnal birth room

patients in standard obstetric units (SOU)

In standard obstetric units, most full time midwives are rostered to work. They follow women during their pregnancy but not through labour. All low-risk pregnant women benefit from 5 prenatal consultations with a general practitioner, a midwife or an obstetrician, then 2 consultations with a midwife in maternity hospital of delivery. Couples have got the option to elaborate a birth project if desired.

No interventions assigned to this group

Interventions

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alternative midwifery units (AMU)

Alternative midwifery birth units are a new model of care in France in which the midwife is the primary health care professional caring for low-risk pregnant women, as opposed to those cared for by an obstetrician-led medical team. Accordingly, alternative midwifery birth units also provide a space within which midwives can practice to their fullest potential with more professional autonomy than in a traditional obstetric setting. These birth units emphasizes care that promotes normal physiologic pregnancy and labor and supports the natural ability of women to experience birth with minimum or no routine intervention.

Alternative midwifery birth units named Filière physiologique co-exist in the same building on the same site as a hospital or host obstetric unit. In the event a laboring women needs comprehensive emergency obstetric care, she can be transferred immediatly in a conventionnal birth room

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No