Clinical trial NCT02298569: Early Postnatal Discharge in a French Perinatal Network
Official title: Early Postnatal Discharge in a French Perinatal Network
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Complications Nos
Labor/Delivery Problems Nos
Vitality; Newborn
Keywords: patient discharge
hospital readmission
postnatal care
Home Care Services
Cost-Benefit Analysis
Personal satisfaction
Community Care Networks
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Réseau Périnatal Alpes-Isere
First posted: 2014-11-24
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of early discharge
timeFrame: 15 days after delivery
Secondary outcomes:
measure: rehospitalization or emergency visits for mothers and babies
timeFrame: from postnatal discharge up to 15 days after delivery
measure: continuation of breastfeeding
timeFrame: 60 days after delivery
measure: maternal satisfaction
timeFrame: 45 days after delivery
measure: maternal depression
timeFrame: 45 days after delivery
measure: maternal quality of life
timeFrame: 45 days after delivery
measure: satisfaction about the medical feed back after discharge
timeFrame: 45 - 60 days after delivery
measure: cost effectiveness
timeFrame: 15 days
measure: associated factors to early discharge
timeFrame: 15 days
measure: compliance to french guidelines
timeFrame: 15 days
measure: mother-infant bonding
timeFrame: 15 days after delivery
Other outcomes:
Locations:
city: Echirolles
country: France
facility: Clinique des Cèdres
city: Grenoble
country: France
facility: Clinique Mutualiste
city: La Tronche
country: France
facility: Hopital Couple Enfant
city: Saint Martin d'Hères
country: France
facility: Clinique Belledonne
city: Voiron
country: France
facility: CH Voiron
Study officials:
affiliation: RPAI (Réseau Périnatal Alpes Isere), CHU Grenoble
name: Claudine MARTIN
role: PRINCIPAL_INVESTIGATOR
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