Early Postnatal Discharge in a French Perinatal Network (SORPRISE)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Pregnancy Complications Nos; Vitality; Newborn; Labor/Delivery Problems Nos

Treatments: Behavioral: multi-pronged program to improve early postpartum discharge

Study type: Interventional

Funder types: Other

Identifiers

NCT02298569

DCIC 13 17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

800 participants in 2 patient groups

Phase 1 (before multi-pronged program)

No Intervention group

Description:

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

Phase 2 (after multi-pronged program)

Experimental group

Description:

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

Treatment:

Behavioral: multi-pronged program to improve early postpartum discharge