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ISRCTN
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ISRCTN98146741
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DOI
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10.1186/ISRCTN98146741
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Leave alone or Induce for the Big BabY
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Scientific title
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Acronym
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LIBBY
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Serial number at source
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G0000515
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Study hypothesis
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Does induction of labour for suspected fetal macrosomia confer maternal or fetal benefits?
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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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Pilot study for 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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Suspected fetal macrosomia
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Participants - inclusion criteria
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Not provided at time of registration.
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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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26/07/1999
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Anticipated end date
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18/02/2003
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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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72 in each group (total = 144)
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Interventions
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Not provided at time of registration.
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Primary outcome measure(s)
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1. Fetal birth trauma (Erbs palsy or any fracture, or neonatal convulsions or intra-cerebral haemorrhage or need for admission to intensive care
2. Instrumental vaginal delivery
3. Caesarean section
4. Maternal injury
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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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2000 pilot results within http://www.ncbi.nlm.nih.gov/pubmed/10796221
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Contact name
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Professor
James G
Thornton
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Address
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Department of Obstetrics and Gynaecology
The University of Nottingham University Park
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RD
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Country
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United Kingdom
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Tel
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+44 (0)115 951 5151
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Fax
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+44 (0)115 951 3666
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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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21/09/2000
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Last edited
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17/05/2011
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Date ISRCTN assigned
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21/09/2000
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