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ISRCTN
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ISRCTN52175236
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ClinicalTrials.gov identifier
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Public title
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The CIRCLE Trial - Cerclage in Relation to Cervical LEngth.
A clinical study to determine the effects of cervical scanning and cervical stitches in preventing preterm labour
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Scientific title
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Acronym
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CIRCLE
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Serial number at source
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RJ1 04/0199
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Not provided at time of registration
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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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Preterm labour
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Participants - inclusion criteria
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Pregnant women at high risk of preterm labour.
Eligibility criteria: any pregnant woman, with a singleton pregnancy, between 16-24 weeks of pregnancy, with a history of one or more previous spontaneous deliveries prior to 34 weeks.
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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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01/11/2003
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Anticipated end date
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30/11/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1890
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Interventions
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Intervention group: Therapeutic cervical suture if cervical canal shortens to ≤20 mm
Control group: Elective cervical suture will only be inserted if the past obstetric history is suggestive of cervical incompetence
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Primary outcome measure(s)
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Not provided at time of registration
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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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Tommy's The Baby Charity
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Trial website
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Publications
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Contact name
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Prof
Andrew
Shennan
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Address
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Maternal and Fetal Research Unit
10th floor North Wing
St Thomas' Hospital
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)207 188 3640
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Email
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andrew.shennan@kcl.ac.uk
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Sponsor
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Guy's and St Thomas' NHS Foundation Trust
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Address
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Research and Development
Ground Floor, West Wing
Counting House, Guys Hospital
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)207 188 5731
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Email
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Jeff.Brazel@gstt.sthames.nhs.uk
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Date applied
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05/10/2004
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Last edited
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04/01/2012
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Date ISRCTN assigned
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17/01/2005
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