Randomised trial of cervical cerclage in women with a short cervix identified by routine sonography at 23 weeks of pregnancy
| ISRCTN | ISRCTN61066532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61066532 |
| Protocol serial number | REC00302 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 02/12/2008
- 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
Dr Kypros Nicolaides
Scientific
Scientific
King's College Hospital
Harris Birthright Research Centre for Fetal Medicine
Denmark Hill
London
SE5 8RX
United Kingdom
| Phone | +44 020 7346 3040 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Objectives: to measure the possible benefit of cervical cerclage in women with a very short cervix identified during routine sonographic assessment of cervical length at 23 weeks of gestation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and childbirth: Pregnancy |
| Intervention | Randomised to cervical cerclage or to expectant management |
| Intervention type | Other |
| Primary outcome measure(s) |
Spontaneous pre-term delivery at less than or equal to 32 weeks in the two groups |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 250 |
| Key inclusion criteria | Women with singleton pregnancies attending for routine antenatal care at King's College Hospital. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/1998 |
| Date of final enrolment | 01/12/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College Hospital
London
SE5 8RX
United Kingdom
SE5 8RX
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 | 05/06/2004 | Yes | No |
