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ISRCTN
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ISRCTN61066532
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ClinicalTrials.gov identifier
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Public title
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Randomised trial of cervical cerclage in women with a short cervix identified by routine sonography at 23 weeks of pregnancy
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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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REC00302
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Study hypothesis
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Objectives: to measure the possible benefit of cervical cerclage in women with a very short cervix identified during routine sonographic assessment of cervical length at 23 weeks of gestation.
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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: Pregnancy
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Participants - inclusion criteria
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Women with singleton pregnancies attending for routine antenatal care at King's College Hospital.
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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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01/12/1998
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Anticipated end date
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01/12/2000
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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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250
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Interventions
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Randomised to cervical cerclage or to expectant management
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Primary outcome measure(s)
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Spontaneous pre-term delivery at less than or equal to 32 weeks in the two groups
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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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NHS Executive London (UK)
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/ 15183621
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Contact name
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Dr
Kypros
Nicolaides
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Address
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King's College Hospital
Harris Birthright Research Centre for Fetal Medicine
Denmark Hill
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City/town
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London
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Zip/Postcode
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SE5 8RX
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Country
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United Kingdom
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Tel
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+44 020 7346 3040
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Fax
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+44
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Email
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Sponsor
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NHS R&D Regional Programme 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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23/01/2004
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Last edited
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02/12/2008
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Date ISRCTN assigned
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23/01/2004
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