Compare 2 Models of Midwifery Care in Maternity CarePhysioCareNCT05483101
Personalized Support Care in Alternative Midwifery Birth Units Versus Traditional Units in France : Effects on Perinatal Health and Outcomes
An observational study of Compare 2 Models of Midwifery Care in Maternity Care, run by Rennes University Hospital at 3 sites in France.
Trial summary
Most pregnancies and deliveries in France occur without complication. According to the 2016 Perinatal Survey, 2/3 of births are carried out by spontaneous vaginal delivery with midwife support in most cases. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Compare 2 Models of Midwifery Care in Maternity Care
- What is being tested?
- Alternative birth units
- How many people
- 597 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Sep 2022to 12 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who planned to give birth in a maternity hospital involved in the study, with a low risk pregnancy
Who may be able to join
- Low-risk pregnancy according to the HAS clinical practice recommendations (2016): follow-up classified A (without particularity) provided indifferently by a FS or a physician; eligibility if follow-up classified A1 or A2 after advice from an ob-gyn and/or another specialist.
- Gestational age between 34 and 39 weeks of amenorrhea
- Single pregnancy
- Maternal age ≥ 18 et < 40 years old
- Patient who planned to give birth in a maternity hospital involved in the study.
- Having been informed about the protocol and not having expressed opposition to participate in the PhysioCare study.
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- Non-inclusion criteria:
- Psychiatric history or depression with medication
- Anonymous childbirth
- History of caesarean section
- Undeclared pregnancy, not or poorly followed up (no blood/urinary check-ups carried out during pregnancy and/or no monthly follow-up with medical consultation)
- Couples unable to speak French
- Non-affiliation of patient to a social security scheme
- Adult persons subject to legal protection ; persons deprived of their liberty
Who cannot join
- Fetal death or medical termination of pregnancy after inclusion
- Death of the child at birth
- Premature birth < 37 weeks of age
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Simone Veil
Eaubonne, 95600
Clinique Mutualiste La Sagesse
Rennes, 35000
Rennes University Hospital
Rennes, 35000
About this study
Official title: Accompagnement de la Grossesse et de la Naissance en filière Physiologique Par Rapport en filière Conventionnelle : Effet Sur la Voie d'Accouchement et la santé périnatale
Most pregnancies and deliveries in France occur without complication. According to the 2016 Perinatal Survey, 2/3 of births are carried out by spontaneous vaginal delivery with midwife support in most cases. Although the impact of lack of care is now well recognized, literature reveals that overmedicalization of pregnancy and birth follow-up is not associated with better health outcomes for women and children. Rather, it may have a deleterious impact, in addition to unnecessary health care costs. Recent national and international guidelines in the management of normal childbirth support the facilitation of physiologic labor and the minimization of non-medically justified interventions, particularly for women at low obstetric risk.
Providing specific places to support low-rick pregnant women is an opportunity to preserve physiology.
Read more
In France, 4 innovative care units called Filières Physiologiques (FP), have been developed on an experimental model within hospital structures in recent years. The FPs, unlike freestanding midwifery units, allow a non-medicalized birth within a maternity hospital, with immediate care of the pregnant women and/or their child in case of vital emergency. A personalized follow-up with a midwife from the beginning of the pregnancy, birth and parenthood preparation classes and delivery is proposed to couples wishing to.
Existing studies in France and abroad show that support outside the conventional care network does not increase perinatal morbidity and improves the experience of childbirth, with a positive influence on the establishment of the mother-child bond and the psychological state of the parents in postpartum. In addition, several studies conducted abroad suggest that follow-up by a midwife could reduce the costs of perinatal care for the health system. However, these studies were conducted abroad, with different structures of follow-up in FP.
A care approach, as proposed in the FPs, with physiological accompaniment of childbirth by a midwife who is available and listens to the couple (the "one-to-one" principle with individual support for the woman) would improve the experience of couples, reduce the stress, fear and pain of labor, and diminish the feeling of insecurity. Other studies suggest that psychosomatic support during pregnancy could reduce the risk of postpartum depression, which is a public health issue.
This study suggest that FP care for women at low obstetrical risk, as compared with conventionnal birth care unit, would promote spontaneous vaginal birth without instrumental extraction. Another hypothesis is that this management would improve salutogenesis indicators, the birth experience of couples, the establishment of the mother-child bond, and the psychological state of parents in the postpartum period. FP care could also be more efficient than conventionnal birth care unit from the community's perspective.
Read the detailed description
This study consists in a prospective multicenter cohort, exposed/unexposed, recruiting 567 low-risk pregnant women in 3 French maternity hospitals from septembre 2022, between 34 and 39 weeks of amenorrhea, matched by center and parity (189 in alternative units and 378 in conventional units). Data will be collected from medical record and questionnaires completed by women and partners at inclusion, 2 days, 3 and 6 weeks postpartum (Mother-to-Infant Bonding Scale; Maternal Childbirth Experience Assessment Questionnaire; First-Time Father Questionnaire; Peritraumatic Distress Inventory; Impact of Event Scale-Revised; Edinburgh Postnatal Depression Scale). Semi-structured interviews to assess women's, partners' and professionals' perceptions of care will be conducted on a sample of couples and midwives. Costs included all costs to the health system for the whole pregnancy up to 6 weeks postpartum, and outcomes will be quality-adjusted life years (QALY) gained. Multivariate intention-to-treat statistical analyses (linear/logistic regression with propensity score, IPTW) will be performed.
Benefits to families through increased knowledge of midwifery care's impact on birth process and parents' birth experience.
This could allow for expansion of alternative birth units in other health care settings.
- Being tested
- Alternative birth units
- Keywords
- Midwife-led care, midwifery birth units, physiologic birth, continuity of patient care, humanized care, quality of health care, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative birth unitsOther
Midwife-led alternative 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 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 birth units named "Filière physiologique (FP) 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.
| Study group | Role | What they receive |
|---|---|---|
| alternative units | In alternative birth units : personalized follow-up with a midwife from the beginning of pregnancy, birth and parenthood preparation classes and delivery (birth room). Receives: Other: Alternative birth units | |
| conventional units | In standard maternity care, 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery according to care of pregnant women in alternative midwifery birth units versus traditional birth units
Rate of spontaneous vaginal delivery versus instrumental vaginal delivery and cesarean section
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start2 Sep 2022
- Primary completion12 May 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare 2 Models of Midwifery Care in Maternity CareStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronan GARLANTEZEC, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483101
- Sponsor's protocol ID
- 35RC20_8988_PhysioCare
- Acronym
- PhysioCare
- Status last verified
- Sep 2024
- First submitted
- 28 Jul 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accompagnement de la Grossesse et de la Naissance en filière Physiologique Par Rapport en filière Conventionnelle : Effet Sur la Voie d'Accouchement et la santé périnatale
- ClinicalTrials.gov ID
- NCT05483101
- Acronym / sponsor ID
- PhysioCare / 35RC20_8988_PhysioCare
- Keywords
- Midwife-led care, midwifery birth units, physiologic birth, continuity of patient care, humanized care, quality of health care, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most pregnancies and deliveries in France occur without complication. According to the 2016 Perinatal Survey, 2/3 of births are carried out by spontaneous vaginal delivery with midwife support in most cases. Although the impact of lack of care is now well recognized, literature reveals that overmedicalization of pregnancy and birth follow-up is not associated with better health outcomes for women and children. Rather, it may have a deleterious impact, in addition to unnecessary health care costs. Recent national and international guidelines in the management of normal childbirth support the facilitation of physiologic labor and the minimization of non-medically justified interventions, particularly for women at low obstetric risk.
Providing specific places to support low-rick pregnant women is an opportunity to preserve physiology.
In France, 4 innovative care units called Filières Physiologiques (FP), have been developed on an experimental model within hospital structures in recent years. The FPs, unlike freestanding midwifery units, allow a non-medicalized birth within a maternity hospital, with immediate care of the pregnant women and/or their child in case of vital emergency. A personalized follow-up with a midwife from the beginning of the pregnancy, birth and parenthood preparation classes and delivery is proposed to couples wishing to.
Existing studies in France and abroad show that support outside the conventional care network does not increase perinatal morbidity and improves the experience of childbirth, with a positive influence on the establishment of the mother-child bond and the psychological state of the parents in postpartum. In addition, several studies conducted abroad suggest that follow-up by a midwife could reduce the costs of perinatal care for the health system. However, these studies were conducted abroad, with different structures of follow-up in FP.
A care approach, as proposed in the FPs, with physiological accompaniment of childbirth by a midwife who is available and listens to the couple (the "one-to-one" principle with individual support for the woman) would improve the experience of couples, reduce the stress, fear and pain of labor, and diminish the feeling of insecurity. Other studies suggest that psychosomatic support during pregnancy could reduce the risk of postpartum depression, which is a public health issue.
This study suggest that FP care for women at low obstetrical risk, as compared with conventionnal birth care unit, would promote spontaneous vaginal birth without instrumental extraction. Another hypothesis is that this management would improve salutogenesis indicators, the birth experience of couples, the establishment of the mother-child bond, and the psychological state of parents in the postpartum period. FP care could also be more efficient than conventionnal birth care unit from the community's perspective.
Detailed description
This study consists in a prospective multicenter cohort, exposed/unexposed, recruiting 567 low-risk pregnant women in 3 French maternity hospitals from septembre 2022, between 34 and 39 weeks of amenorrhea, matched by center and parity (189 in alternative units and 378 in conventional units). Data will be collected from medical record and questionnaires completed by women and partners at inclusion, 2 days, 3 and 6 weeks postpartum (Mother-to-Infant Bonding Scale; Maternal Childbirth Experience Assessment Questionnaire; First-Time Father Questionnaire; Peritraumatic Distress Inventory; Impact of Event Scale-Revised; Edinburgh Postnatal Depression Scale). Semi-structured interviews to assess women's, partners' and professionals' perceptions of care will be conducted on a sample of couples and midwives. Costs included all costs to the health system for the whole pregnancy up to 6 weeks postpartum, and outcomes will be quality-adjusted life years (QALY) gained. Multivariate intention-to-treat statistical analyses (linear/logistic regression with propensity score, IPTW) will be performed.
Benefits to families through increased knowledge of midwifery care's impact on birth process and parents' birth experience.
This could allow for expansion of alternative birth units in other health care settings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alternative units | – | Other: Alternative birth unitsIn alternative birth units : personalized follow-up with a midwife from the beginning of pregnancy, birth and parenthood preparation classes and delivery (birth room). |
| conventional units | – | –In standard maternity care, 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who planned to give birth in a maternity hospital involved in the study, with a low risk pregnancy
Key inclusion criteria (14 listed)
- Low-risk pregnancy according to the HAS clinical practice recommendations (2016): follow-up classified A (without particularity) provided indifferently by a FS or a physician; eligibility if follow-up classified A1 or A2 after advice from an ob-gyn and/or another specialist.
- Gestational age between 34 and 39 weeks of amenorrhea
- Single pregnancy
- Maternal age ≥ 18 et < 40 years old
- Patient who planned to give birth in a maternity hospital involved in the study.
Key exclusion criteria (3 listed)
- Fetal death or medical termination of pregnancy after inclusion
- Death of the child at birth
- Premature birth < 37 weeks of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternative birth unitsMidwife-led alternative 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 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 birth units named "Filière physiologique (FP) 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. | Other | alternative units |
Primary outcome
Mode of delivery according to care of pregnant women in alternative midwifery birth units versus traditional birth units
Time frame: up to 5 weeks
Rate of spontaneous vaginal delivery versus instrumental vaginal delivery and cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronan GARLANTEZEC principal investigator
Rennes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compare 2 Models of Midwifery Care in Maternity Care, run by Rennes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of delivery according to care of pregnant women in alternative midwifery birth units versus traditional birth units (time frame: up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.