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
Secondary identifying numbers REC00302
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesObjectives: 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) studiedPregnancy and childbirth: Pregnancy
InterventionRandomised to cervical cerclage or to expectant management
Intervention typeOther
Primary outcome measureSpontaneous pre-term delivery at less than or equal to 32 weeks in the two groups
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/1998
Completion date01/12/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants250
Key inclusion criteriaWomen with singleton pregnancies attending for routine antenatal care at King's College Hospital.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/12/1998
Date of final enrolment01/12/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College Hospital
London
SE5 8RX
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

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 05/06/2004 Yes No