NCT05483101: PhysioCare

Personalized Support Care in Alternative Midwifery Birth Units Versus Traditional Units in France : Effects on Perinatal Health and Outcomes

Completed Last updated 2 October 2024

What this trial tests

trial testing Alternative birth units in Compare 2 Models of Midwifery Care in Maternity Care in 597 participants. Completed in 12 July 2023.

Timeline

2 September 2022

Primary endpoint
12 May 2023

12 July 2023

Quick facts

Lead sponsor	Rennes University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	597
Start date	2 September 2022
Primary completion	12 May 2023
Estimated completion	12 July 2023
Sites	3 locations across France

Drugs / interventions tested

• Alternative birth units

Conditions studied

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

Sponsor

Rennes University Hospital

Who can join

Adults 18 to 40, female only, with Compare 2 Models of Midwifery Care in Maternity Care. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.