Early Postnatal Discharge in a French Perinatal Network
- Conditions
- Labor/Delivery Problems NosVitality; NewbornPregnancy Complications Nos
- Interventions
- Behavioral: multi-pronged program to improve early postpartum discharge
- Registration Number
- NCT02298569
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 800
"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
- person deprived of liberty
- person who does not speak French
- person not covered by health insurance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 2 (after multi-pronged program) multi-pronged program to improve early postpartum discharge 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
- Primary Outcome Measures
Name Time Method rate of early discharge 15 days after delivery number of early postnatal discharges (2-72 hours after delivery) among eligible population: i.e. low risk mothers and low risk newborns, before and after a major change in the organization of integrated managed care, in a perinatal network. The rate of emergency medical consultations and or re-hospitalization for mothers and babies will be recorded among women who had an early postnatal discharge compared to women with standard hospital stay. Every eligible women will have a phone interview 15 days after delivery to assess the duration of hospitalization in the maternity ward and to report any emergency medical consultation or rehospitalization after discharge of mother and baby.
- Secondary Outcome Measures
Name Time Method rehospitalization or emergency visits for mothers and babies from postnatal discharge up to 15 days after delivery number of rehospitalization or emergency medical visits for mothers and/or babies observed during the first 15 days after delivery, among the eligible population i.e. low risk mothers and low risk newborns, whatever the duration of their hospital stay. Every eligible women will have a phone interview 15 days after delivery to assess type of hospital discharge (early or standard), and if necessary, report any emergency medical consultation or rehospitalization after hospital discharge for baby and/or mother
continuation of breastfeeding 60 days after delivery number of women continuing breastfeeding beyond 60 days postpartum, before and after intervention. Every women who had early postnatal discharge will have a phone interview 60 days after delivery to assess the duration of breastfeeding
maternal depression 45 days after delivery postnatal depression defined as a score higher than 12 on Edinburgh Postpartum Scale (EDPS) among women with early discharge from hospital will be compared before and after the intervention. Every women who had early postnatal discharge, will be asked to complete the EDPS form (on line or by post) 45 days after delivery to assess maternal depressive symptoms
maternal quality of life 45 days after delivery mean scores of Short-Form Health Survey (SF-12) among women with early discharge from hospital to be compared before and after intervention. Every women who proceeded to early postnatal discharge, will be asked to complete SF-12 form (on line or by post) 45 days after delivery to asses maternal quality of life
associated factors to early discharge 15 days information about early discharge during pregnancy, socioeconomic factors, medical antecedents, type of prenatal follow-up, assessed by phone call interview with every eligible mother
satisfaction about the medical feed back after discharge 45 - 60 days after delivery mean scores of satisfaction adapted from the questionnaire Satisfaction of the Patients at the Hospital in Region Aquitaine-Committee of evaluation 2009(SAPHORA-Committee of evaluation 2009) French form, about the quality of medical feedback after early discharge from hospital to be compared before and after intervention. Every community practitioner (general practitioner, paediatrician, midwife) who saw the mothers and baby during follow-up will be asked to complete a form , 45 or 60days after delivery to assess the quality of medical information given by the hospital to community practitioners, and the quality of the discharge summary
cost effectiveness 15 days cost of early discharge, that is cost of hospitalization and cost of follow-up and cost of readmission to be compared with cost of routine hospitalization and eventual readmission for healthy mothers and babies, assessed during phone interviews with mothers
compliance to french guidelines 15 days compliance to French guidelines edited in 2014 about the organization of early discharge and home follow-up to be assessed by phone interview with midwife who performed home follow-up of mothers after early discharge
maternal satisfaction 45 days after delivery maternal satisfaction based on adapted WOMen's views of Birth Postnatal Satisfaction Questionnaire mean scores (WOMBSQ questionnaire). The WOMen's views of Birth Postnatal Satisfaction Questionnaire (WOMBSQ questionnaire) asks about quality of postnatal care provided both in the maternity ward during the hospital stay, and at home by the midwife during 2-4 days follow-up. The scores will be compared before and after the intervention. Every women who had early postnatal discharge, will be asked to complete the WOMen's views of Birth Postnatal Satisfaction Questionnaire form (on line or by post) 45 days after delivery
mother-infant bonding 15 days after delivery mean Mother to Infant bonding scale (MIB score ) at 15 days after delivery, among eligible population that is low risk mothers and low risk newborns, whatever the duration of hospital stay. Every eligible women will get a form (on line or by post) 15 days after delivery to assess the feelings of mother towards their new baby. Mothers will be asked during the phone interview how they would like to complete this form : paper sent by post, or on line.
Trial Locations
- Locations (5)
Clinique des Cèdres
🇫🇷Echirolles, France
Hopital Couple Enfant
🇫🇷La Tronche, France
Clinique Mutualiste
🇫🇷Grenoble, France
Clinique Belledonne
🇫🇷Saint Martin d'Hères, France
CH Voiron
🇫🇷Voiron, France