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ISRCTN
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ISRCTN00522952
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ClinicalTrials.gov identifier
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Public title
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A cluster randomised trial to investigate the use of a decision aid for the diagnosis of active labour in term pregnancy
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Scientific title
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Acronym
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TELSiS
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Serial number at source
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CZH/4/245
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Study hypothesis
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The primary aim of this study is to compare the effectiveness of a decision aid for diagnosis of active labour, with standard care in terms of maternal and neonatal outcomes, costs and costs savings. A secondary aim is to explore the impact of the intervention on women.
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Ethics approval
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Approved by the Multicentre Research Ethics Committee for Scotland B (ref: 05/MRE10/31)
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Study design
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A 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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Diagnosis of active labour
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Participants - inclusion criteria
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Women who were primiparous, at term, and assessed as low risk
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Participants - exclusion criteria
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1. Multiparous
2. Pre-term
3. Multiple pregnancy
4. Medical or obstetric complications
5. Under 16 years of age
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Anticipated start date
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31/03/2005
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Anticipated end date
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30/06/2007
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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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4,800 (12 clusters, 400 women in each cluster)
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Interventions
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Diagnosis of active labour using algorithm vs usual care (labour assessment by standard methods)
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Primary outcome measure(s)
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Use of oxytocin for augmentation of labour
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Secondary outcome measure(s)
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1. Interventions in labour i.e. artificial rupture of membranes (ARM)
2. Vaginal examination (VE)
3. Use of analgesia
4. Mode of delivery
5. Management of women "not in labour"
6. Intrapartum complications
7. Neonatal outcome
8. Unplanned out-of-hospital births
9. NHS cost and cost to women
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Sources of funding
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Chief Scientist Office, Health Service Research Committee, Scotland (UK)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19064606
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Contact name
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Ms
Helen
Cheyne
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Address
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Iris Murdoch Building
University of Stirling
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City/town
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Stirling
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Zip/Postcode
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FK9 4LA
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Country
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United Kingdom
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Email
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h.l.cheyne@stir.ac.uk
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Sponsor
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University of Stirling (UK)
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Address
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-
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City/town
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Stirling
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Zip/Postcode
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FK9 4LA
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Country
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United Kingdom
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Email
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carol.johnstone@stir.ac.uk
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Sponsor website:
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http://www.external.stir.ac.uk
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Date applied
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28/02/2008
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Last edited
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10/12/2008
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Date ISRCTN assigned
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27/03/2008
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