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ISRCTN
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ISRCTN70152691
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ClinicalTrials.gov identifier
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Public title
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A comparison of the effectiveness of prostaglandin gel and tablet preparations in induction of labour at term.
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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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N0016158062
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Study hypothesis
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Is Prostin (dinoprostone) gel more effective in induction of labour than Prostin tablets?
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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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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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Pregnancy and Childbirth: Labour induction
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Participants - inclusion criteria
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Outpatients
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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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01/11/2004
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Anticipated end date
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01/11/2006
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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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165
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Interventions
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Prostil gel vs Prostil tablet
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Primary outcome measure(s)
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1. Mode of delivery and indication
2. Time in labour
3. Number of doses of prostaglandin needed
4. Cervical dilation at transfer to labour Ward.
5. Frequency of artificial rupture of membranes
6. Frequency of oxytocin use
7. Frequency of meconium staining of liquor
8. Frequency of uterine tachysystole/hyperstimulation
9. Frequency of need for foetal blood sampling in labour
10. Frequency of need for neonatal resuscitation or transfer to Neonatal Unit
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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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Hammersmith Hospital NHS Trust (UK)
Hammersmith Hospital Pharmacy
NHS R&D Support Funding 2004/05
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21429067
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Contact name
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Mr
Douglas Keith
Edmonds
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Address
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Women's & Children's Services
Queen Charlottes & Chelsea Hospital
Hammersmith Hospital
Du Cane Road
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City/town
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London
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Zip/Postcode
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W12 0HS
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Country
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United Kingdom
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Tel
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+44 (0)20 8383 5239
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Fax
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+44 (0)20 8383 3419
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Email
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dkedmonds@hhnt.org
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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12/04/2011
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Date ISRCTN assigned
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30/09/2005
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