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ISRCTN
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ISRCTN48614382
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DOI
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10.1186/ISRCTN48614382
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised controlled trial of the clinical impact of an intelligent decision making support tool for labour management using the cardiotocogram
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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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G9721800
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Study hypothesis
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To determine whether an intelligent support system can improve outcomes for mother and baby for current foetal monitoring by reducing human error.
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Lay summary
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Not provided at time of registration
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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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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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Obstetrics and gynaecology
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Participants - inclusion criteria
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All consented pregnancies after 34 weeks gestation with no gross foetal anomaly undergoing electronic foetal monitoring (EFM) in labour
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/06/1999
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Anticipated end date
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31/05/2004
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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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Corrected 19/08/09: data collection on all deliveries (30,000 - 35,000) occurring in the 6 units during the study of the 15,000 monitored in the RCT.
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Interventions
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EFM with and without decision support
Delivery - operative (Caesarean section or forceps) or spontaneous
Added 19/08/09:
Follow-up: One month in first instance. Longer term follow-up will almost certainly occur as part of a paediatric developmental study.
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Primary outcome measure(s)
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Operative delivery rates for mother. Cord blood gas analysis, admissions to NICU, neonatal encephalopathy and perinatal mortality rates for baby.
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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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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Professor
Keith
Greene
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Address
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Perinatal Research Group
Postgraduate Medical School
University of Plymouth
Maternity Unit
Derriford Hospital
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City/town
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Plymouth
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Zip/Postcode
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PL6 8DH
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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16/07/2012
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Date ISRCTN assigned
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25/10/2000
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