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

ISRCTN ISRCTN52175236
DOI https://doi.org/10.1186/ISRCTN52175236
Secondary identifying numbers RJ1 04/0199
Submission date
05/10/2004
Registration date
17/01/2005
Last edited
07/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andrew Shennan
Scientific

Maternal and Fetal Research Unit
10th Floor North Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom

Phone +44 (0)207 188 3640
Email andrew.shennan@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe 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
Study acronymCIRCLE
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPreterm labour
InterventionIntervention 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2003
Completion date30/11/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants1890
Key inclusion criteriaPregnant 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2003
Date of final enrolment30/11/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust
Hospital/treatment centre

Research and Development
Ground Floor, West Wing
Counting House, Guys Hospital
London
SE1 9RT
England
United Kingdom

Phone +44 (0)207 188 5731
Email Jeff.Brazel@gstt.sthames.nhs.uk
ROR logo "ROR" https://ror.org/00j161312

Funders

Funder type

Charity

Tommy's Baby Charity
Private sector organisation / Other non-profit organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2009 Yes No