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ISRCTN
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ISRCTN74323479
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ClinicalTrials.gov identifier
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Public title
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What shall we do with the postdates woman who is not in labour?
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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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N0024112467
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Study hypothesis
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Can we reduce the induction to delivery interval and Caesarean section rate in postdates primigravida women undergoing induction of labour with unfavourable cervix?
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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: Induction of labour
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Participants - inclusion criteria
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100 pregnant primiparous women who have not laboured at or beyond 41 weeks of gestation with cervival length >3 cm.
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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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01/05/2002
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Anticipated end date
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31/12/2003
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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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100
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Interventions
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1. Mifepristone
2. Standard care
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Primary outcome measure(s)
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1. Length of time from induction start (first Prostin) to:
1.1 Onset of labour
1.2 Second stage
1.3 Delivery
1.4.Timing and type of intervention (Caesarian Section, Forceps, Ventouse), if any
2. Antepartum haemorrhage (APH), postpartum haemorrhage (PPH) and other complications
3. Neonatal weight, cord pH and admission to Special Care Baby Unit (SCBU)
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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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Homerton University Hospital NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
Kevin
Harrington
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Address
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Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
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City/town
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London
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Zip/Postcode
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E9 6SR
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Country
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United Kingdom
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Tel
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+44 020 8510 7544
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Fax
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+44 020 8510 7544
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Email
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kevin.harrington@virgin.net
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - 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.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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08/07/2008
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Date ISRCTN assigned
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12/09/2003
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