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ISRCTN
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ISRCTN53994660
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DOI
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10.1186/ISRCTN53994660
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Overview of the Role of Antibiotics in Curtailing Labour and Early delivery
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Scientific title
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Acronym
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ORACLE
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Serial number at source
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G9226450
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Study hypothesis
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The ORACLE trial is designed to test the hypothesis that treatment of women with idiopathic preterm labour or preterm rupture of the membranes (PROM) with broad spectrum antibiotics reduces neonatal mortality and morbidity due to preterm birth
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Lay summary
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Ethics approval
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Added 18/07/2007: Approved by West Midlands Multicentre Research Ethics Committee.
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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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Pregnant women less than 37 weeks gestation either in preterm labour or with premature rupture of membranes (PROM)
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Participants - exclusion criteria
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Need for immediate delivery, contraindications for antibiotics
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Anticipated start date
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01/07/1994
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Anticipated end date
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31/03/2009
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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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10000
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Interventions
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Broad spectrum antibiotics/placebo
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Primary outcome measure(s)
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Neonatal death, Chronic lung disease, Major cerebral pathology
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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 (UK)
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Trial website
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Publications
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1. 2001 ORACLE I results in http://www.ncbi.nlm.nih.gov/pubmed/11293640
2. 2001 ORACLE II results in http://www.ncbi.nlm.nih.gov/pubmed/11293641
3. 2005 ORACLE trials results in http://www.ncbi.nlm.nih.gov/pubmed/15924546
4. 2008 ORACLE I trial results in http://www.ncbi.nlm.nih.gov/pubmed/18804274
5. 2008 ORACLE II trial results in http://www.ncbi.nlm.nih.gov/pubmed/18804276
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Contact name
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Professor
DJ
Taylor
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Address
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Department of Obstetrics & Gynaecology
Clinical Sciences Building
Leicester Royal Infirmary
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City/town
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Leicester
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Zip/Postcode
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LE2 7LX
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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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21/10/2008
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Date ISRCTN assigned
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25/10/2000
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