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 |
| Protocol serial number | RJ1 04/0199 |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust |
| Funder | Tommy's Baby Charity |
- 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
Scientific
Maternal and Fetal Research Unit
10th Floor North Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
| Phone | +44 (0)207 188 3640 |
|---|---|
| andrew.shennan@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | CIRCLE |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 30/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1890 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 30/11/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
