Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00302
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Pregnancy and childbirth: Pregnancy
Intervention
Randomised to cervical cerclage or to expectant management
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Spontaneous pre-term delivery at less than or equal to 32 weeks in the two groups
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1998
Overall trial end date
01/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women with singleton pregnancies attending for routine antenatal care at King's College Hospital.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
250
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/1998
Recruitment end date
01/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
London
SE5 8RX
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/ 15183621