This trial is active, not recruiting.

Conditions pregnancy complications nos, labor/delivery problems nos, vitality; newborn
Treatment multi-pronged program to improve early postpartum discharge
Sponsor University Hospital, Grenoble
Collaborator Réseau Périnatal Alpes-Isere
Start date September 2014
End date January 2017
Trial size 800 participants
Trial identifier NCT02298569, DCIC 13 17


The purpose of this "before-after" study is to determine the effectiveness of a multidimensional intervention to increase the rate for early discharge of low-risk mothers and the healthy newborn in a perinatal network.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(No Intervention)
400 low-risk mothers having given birth without any complication to a healthy newborn are to be recruited in the 5 maternity wards of a French perinatal network consecutively, whatever the duration of their hospital stay
400 low-risk mothers having given birth without any complication to a healthy newborn are to be recruited in the 5 maternity wards of the same French perinatal network 3 months after the intervention (introduction of the multi-pronged program) consecutively, whatever the duration of their hospital stay
multi-pronged program to improve early postpartum discharge team integration and culture change
Better team integration and changes to promote interprofessional collaboration and communication between healthcare providers involved in pre- and post-natal care in a perinatal network. Transition optimization: all involved healthcare professionals will complete a specific form during pregnancy and hospitalization to coordinate support safe process, and to improve quality transitions to outpatient midwives and pediatrician. A check-list will be completed by the mother to assess whether she agrees to early discharge and that she is aware of its conditions Implementation of best practices about early discharge after delivery to improve safety of early discharge particularly for neonates at risk (jaundice and dehydration).

Primary Outcomes

rate of early discharge
time frame: 15 days after delivery

Secondary Outcomes

rehospitalization or emergency visits for mothers and babies
time frame: from postnatal discharge up to 15 days after delivery
continuation of breastfeeding
time frame: 60 days after delivery
maternal satisfaction
time frame: 45 days after delivery
maternal depression
time frame: 45 days after delivery
maternal quality of life
time frame: 45 days after delivery
satisfaction about the medical feed back after discharge
time frame: 45 - 60 days after delivery
cost effectiveness
time frame: 15 days
associated factors to early discharge
time frame: 15 days
compliance to french guidelines
time frame: 15 days
mother-infant bonding
time frame: 15 days after delivery

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: "1" low risk mothers ith uncomplicated pregnancy and birth defined as - lack of mental disability - lack of referred problems about mother to infant bonding - lack of precarious state - vaginal delivery without bleeding more than 500cc - lack of postpartum complications during hospitalization "2" low risk baby defined as - singleton - gestational age >= 38 weeks - apgar score > 7 at 5 minutes life - normal weight expected for gestational age - lack of infection, or jaundice Exclusion Criteria: - person deprived of liberty - person who does not speak French - person not covered by health insurance

Additional Information

Official title Early Postnatal Discharge in a French Perinatal Network
Principal investigator Claudine MARTIN
Description In March 2014, the French Health Authorities edited new guidelines about early discharge after delivery. Early discharge is defined as a discharge during the 72 hours following vaginal delivery of low-risk mothers and their healthy newborn. These guidelines defined the conditions of eligibility for early discharge for mothers and babies, and the different criteria of their follow-up at home by midwives . The average length of stay following normal delivery is higher in France than in other European countries: eg : 4.3 days in France vs 2.2 days in Sweden (OECD indicators 2011) On the other hand, according to an investigation conducted by a patients association, 38% women declared that they felt that their hospitalization was too long after their baby's birth, but their request for a shorter stay had not been taken into account by hospital caregivers. The investigators hypothesis is that the rate of early discharge could be increased by a multi-pronged program coordinated in a perinatal network, and could improve quality of postpartum care, and women's satisfaction. The "Réseau Périnatal Alpes Isère" is a perinatal network located in French Alps region. Its purpose is to coordinate 5 maternity services an organization of midwives providing pre and postnatal home care, for about 10000 births annually. In 2010, according to the hospital database provided by the Medical Information Systems Program, early discharge concerned only 4.1% of mothers between 0 and 48 hours after delivery . At the same time, 65% of women could be considered as at low risk, considering they gave birth to a healthy singleton, born after 38 weeks of gestation by vaginal delivery. This rate is not precise, in view of the lack of availability of documented rate of non-eligibility for early discharge such as non- eutrophic babies, or adverse events during postpartum and the neonatal period.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.