Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
02/12/2008
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

Dr Kypros Nicolaides

ORCID ID

Contact details

King's College Hospital
Harris Birthright Research Centre for Fetal Medicine
Denmark Hill
London
SE5 8RX
United Kingdom
+44 020 7346 3040

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/ 15183621

Publication citations

Additional files

Editorial Notes