Contact information
Type
Scientific
Primary contact
Prof Andrew Shennan
ORCID ID
Contact details
Maternal and Fetal Research Unit
10th Floor North Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
+44 (0)207 188 3640
andrew.shennan@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RJ1 04/0199
Study information
Scientific title
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
Acronym
CIRCLE
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Preterm labour
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
30/11/2008
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1890
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2003
Recruitment end date
30/11/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust
Sponsor details
Research and Development
Ground Floor
West Wing
Counting House
Guys Hospital
London
SE1 9RT
United Kingdom
+44 (0)207 188 5731
Jeff.Brazel@gstt.sthames.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Tommy's Baby Charity
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19380124