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Pregnancy Complications NosSORPRISENCT02298569

Early Postnatal Discharge in a French Perinatal Network

A study testing multi-pronged program to improve early postpartum discharge in people with Pregnancy Complications Nos and Labor/Delivery Problems Nos, run by University Hospital, Grenoble at 5 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
multi-pronged program to improve early postpartum discharge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
5 sitesFrance
Study dates
Sep 2014to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • "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
Show all 12Show fewer
  • "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

Who cannot join

  • person deprived of liberty
  • person who does not speak French
  • person not covered by health insurance

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Clinique des Cèdres

    Échirolles, 38432

  • Clinique Mutualiste

    Grenoble, 38000

  • Hopital Couple Enfant

    La Tronche, 38043

  • Clinique Belledonne

    Saint-Martin-d'Hères, 38400

  • CH Voiron

    Voiron, 38506

Other trials in France

About this study

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.

Read the 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.

Being tested
multi-pronged program to improve early postpartum discharge
Keywords
patient discharge, hospital readmission, postnatal care, Home Care Services, Cost-Benefit Analysis, Personal satisfaction, Community Care Networks
Medical subject headings
Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multi-pronged program to improve early postpartum dischargeBehavioural

    Also called team integration and culture change, transition optimisations, implementation of best practices

    Better team integration and changes to promote interprofessional collaboration and communication between healthcare providers involved in pre- and post-natal care in a perinatal network.

    Transition optimization: all involved healthcare professionals will complete a specific form during pregnancy and hospitalization to coordinate support safe process, and to improve quality transitions to outpatient midwives and pediatrician. A check-list will be completed by the mother to assess whether she agrees to early discharge and that she is aware of its conditions Implementation of best practices about early discharge after delivery to improve safety of early discharge particularly for neonates at risk (jaundice and dehydration).

Study groups in NCT02298569
Study groupRoleWhat they receive
Phase 1 (before multi-pronged program)No intervention400 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)Experimental400 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
Receives: Behavioral: multi-pronged program to improve early postpartum discharge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 days after delivery

Secondary outcomes (10)

  1. 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

    Measured: from postnatal discharge up to 15 days after delivery

  2. 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

    Measured: 60 days after delivery

  3. 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

    Measured: 45 days after delivery

  4. 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

    Measured: 45 days after delivery

  5. 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

    Measured: 45 days after delivery

  6. 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

    Measured: 45 - 60 days after delivery

  7. 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

    Measured: 15 days

  8. 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

    Measured: 15 days

  9. 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

    Measured: 15 days

  10. 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.

    Measured: 15 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2017 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02298569
Sponsor's protocol ID
DCIC 13 17
Acronym
SORPRISE
Status last verified
Mar 2016
First submitted
29 Aug 2014
Last updated
24 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Liu S. Rate of neonatal hospital readmission after discharge following birth. Canadian Perinatal Health Report 2003; 104-106. http://www.hc-sc.gc.ca/pphb-dgspsp/rhs-ssg/index.html

  • Ellberg L, Hogberg U, Lundman B, Kallen K, Hakansson S, Lindh V. Maternity care options influence readmission of newborns. Acta Paediatr. 2008 May;97(5):579-83. doi: 10.1111/j.1651-2227.2008.00714.x.

    PubMed 18394103

  • Boulvain M, Perneger TV, Othenin-Girard V, Petrou S, Berner M, Irion O. Home-based versus hospital-based postnatal care: a randomised trial. BJOG. 2004 Aug;111(8):807-13. doi: 10.1111/j.1471-0528.2004.00227.x.

    PubMed 15270928

  • Oddie SJ, Hammal D, Richmond S, Parker L. Early discharge and readmission to hospital in the first month of life in the Northern Region of the UK during 1998: a case cohort study. Arch Dis Child. 2005 Feb;90(2):119-24. doi: 10.1136/adc.2003.040766.

    PubMed 15665161

  • Sainz Bueno JA, Romano MR, Teruel RG, Benjumea AG, Palacin AF, Gonzalez CA, Manzano MC. Early discharge from obstetrics-pediatrics at the Hospital de Valme, with domiciliary follow-up. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):714-26. doi: 10.1016/j.ajog.2005.01.015.

    PubMed 16150265

  • Johansson K, Aarts C, Darj E. First-time parents' experiences of home-based postnatal care in Sweden. Ups J Med Sci. 2010 May;115(2):131-7. doi: 10.3109/03009730903431809.

    PubMed 20074000

  • Shaw E, Levitt C, Wong S, Kaczorowski J; McMaster University Postpartum Research Group. Systematic review of the literature on postpartum care: effectiveness of postpartum support to improve maternal parenting, mental health, quality of life, and physical health. Birth. 2006 Sep;33(3):210-20. doi: 10.1111/j.1523-536X.2006.00106.x.

    PubMed 16948721

  • Bravo P, Uribe C, Contreras A. Early postnatal hospital discharge: the consequences of reducing length of stay for women and newborns. Rev Esc Enferm USP. 2011 Jun;45(3):758-63. doi: 10.1590/s0080-62342011000300030.

    PubMed 21710086

  • http://www.sante.gouv.fr/IMG/pdf/Les_naissances_en_2010_et_leur_evolution_depuis_2003.pdf

  • OCDE (2009), Panorama de la santé 2009 : Les indicateurs de l'OCDE, Éditions OCDE.doi : 10.1787/health_glance-2009-fr

  • Smith LF. Postnatal care: development of a psychometric multidimensional satisfaction questionnaire (the WOMBPNSQ) to assess women's views. Br J Gen Pract. 2011 Oct;61(591):e628-37. doi: 10.3399/bjgp11X601334.

    PubMed 22152835

  • Antoniotti S, Baumstarck-Barrau K, Simeoni MC, Sapin C, Labarere J, Gerbaud L, Boyer L, Colin C, Francois P, Auquier P. Validation of a French hospitalized patients' satisfaction questionnaire: the QSH-45. Int J Qual Health Care. 2009 Aug;21(4):243-52. doi: 10.1093/intqhc/mzp021. Epub 2009 Jun 23.

    PubMed 19549673

  • Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.

    PubMed 9817135

  • Edinburgh Depression Scale Translated Government of Western Australia Department of Health www.folkhalsoguiden.se/upload/Psykisk Hälsa/Edinburgh Depression Scale Translated Government of Western Australia Department of Health.pdf

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing multi-pronged program to improve early postpartum discharge in people with Pregnancy Complications Nos and Labor/Delivery Problems Nos, run by University Hospital, Grenoble at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of early discharge (time frame: 15 days after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02298569, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.

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