Clinical Trial: Early Postnatal Discharge in a French Perinatal Network

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Early Postnatal Discharge in a French Perinatal Network

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 Summary:

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,
Sponsor: University Hospital, Grenoble

Current Primary Outcome: rate of early discharge [ Time Frame: 15 days after delivery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• rehospitalization or emergency visits for mothers and babies [ Time Frame: 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 [ Time Frame: 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 satisfaction [ Time Frame: 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
• maternal depression [ Time Frame: 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 [ Time Frame: 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
• satisfaction about the medical feed back after discharge [ Time Frame: 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 [ Time Frame: 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
• associated factors to early discharge [ Time Frame: 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
• compliance to french guidelines [ Time Frame: 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
• mother-infant bonding [ Time Frame: 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.

Original Secondary Outcome:

• rehospitalization or emergency visits for mothers and babies [ Time Frame: 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 [ Time Frame: 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 satisfaction [ Time Frame: 45 days after delivery ]
  maternal satisfaction based on adapted WOMBSQ mean scores. The 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 WOMBSQ form (on line or by post) 45 days after delivery
• maternal depression [ Time Frame: 45 days after delivery ]
  postnatal depression defined as a score higher than 12 on Edimburgh 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 [ Time Frame: 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
• satisfaction about the medical feed back after discharge [ Time Frame: 45 - 60 days after delivery ]
  mean scores of satisfaction adapted from SAPHORA-CE 2009 French form, about the quality of medical feedback after early discharge from hospital to be compared before and after intervention. Every community practionner (general practitionner, 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 practitionners, and the quality of the discharge summary
• cost effectiveness [ Time Frame: 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
• associated factors to early discharge [ Time Frame: 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
• compliance to french guidelines [ Time Frame: 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
• mother-infant bonding [ Time Frame: 15 days after delivery ]
  mean MIB score (Mother to Infant bonding scale) 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.

Dates:
Date Received: August 29, 2014
Date Started: September 2014
Date Completion: April 2017
Last Updated: March 23, 2016
Last Verified: March 2016