Labor/Delivery Problems Nos Clinical Trial
— SORPRISEOfficial title:
Early Postnatal Discharge in a French Perinatal Network
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.
| Status | Active, not recruiting |
| Enrollment | 800 |
| Est. completion date | April 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique des Cèdres | Echirolles | |
| France | Clinique Mutualiste | Grenoble | |
| France | Hopital Couple Enfant | La Tronche | |
| France | Clinique Belledonne | Saint Martin d'Hères | |
| France | CH Voiron | Voiron |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble | Réseau Périnatal Alpes-Isere |
France,
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DOMECQ, S. AUSTRUY, J.VIOT, F. CADIOT, C POURIN. Evaluation de la satisfaction des correspondants externes : Rapport régional, mars 2009. CCECQA -Hôpital Xavier Arnozan -33604 Pessac www.ccecqa.asso.fr
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate of early discharge | 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. | 15 days after delivery | No |
| Secondary | rehospitalization or emergency visits for mothers and babies | 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 | from postnatal discharge up to 15 days after delivery | Yes |
| Secondary | continuation of breastfeeding | 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 | 60 days after delivery | No |
| Secondary | maternal satisfaction | 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 | 45 days after delivery | No |
| Secondary | maternal depression | 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 | 45 days after delivery | No |
| Secondary | maternal quality of life | 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 | 45 days after delivery | No |
| Secondary | satisfaction about the medical feed back after discharge | 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 | 45 - 60 days after delivery | No |
| Secondary | cost effectiveness | 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 | 15 days | No |
| Secondary | associated factors to early discharge | information about early discharge during pregnancy, socioeconomic factors, medical antecedents, type of prenatal follow-up, assessed by phone call interview with every eligible mother | 15 days | No |
| Secondary | compliance to french guidelines | 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 | 15 days | No |
| Secondary | mother-infant bonding | 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. | 15 days after delivery | No |