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ISRCTN
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ISRCTN79350792
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ClinicalTrials.gov identifier
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Public title
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Redesigning postnatal care: a randomised controlled trial of protocol-based, midwifery-led care
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 94/22/26
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Study hypothesis
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Recent government reports have highlighted the need for change in the provision of maternity care. The objective of this study is to develop and implement two new models of postnatal care. The cost-effectiveness of the models will be compared with current practice in a three arm randomised controlled trial. The new models will comprise midwifery-led protocol-based care, aimed at the identification and management of individual women's physical and psychological health problems. They are designed to make more appropriate use of the skills and time of the professionals involved. The role of the midwife will be extended to undertake the postnatal examination, with GP referral based on need. The content and frequency of postnatal consultations will be substantially modified and there will be a reduction in routine monitoring, observations and examinations. In one intervention arm the new model of care will extend until three months postpartum. The findings will have direct implications for delivery of care throughout the National Health Service.
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Cluster randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Childbirth
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Participants - inclusion criteria
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Consenting cluster practices
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Participants - exclusion criteria
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Women expected to move out of the general practice in the post-natal period.
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Anticipated start date
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01/05/1996
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Anticipated end date
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31/03/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2,064
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Interventions
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1. New model of community care
2. Standard community post natal care
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Primary outcome measure(s)
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Outcomes will be assessed by measures of physical and emotional well-being and satisfaction with care.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/14622490
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Contact name
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Prof
Christine
MacArthur
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Address
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Dept of Public Health & Epidemiology
University of Birmingham
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 0121 414 6770
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Fax
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+44 0121 414 7878
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Email
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C.MacArthur@bham.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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27/08/2009
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Date ISRCTN assigned
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25/04/2003
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