Condition category
Pregnancy and Childbirth
Date applied
05/10/2004
Date assigned
17/01/2005
Last edited
07/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes