A randomised controlled trial of interventions to promote external cephalic version (ECV) at term

ISRCTN ISRCTN74892692
DOI https://doi.org/10.1186/ISRCTN74892692
Secondary identifying numbers 547
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
29/01/2010
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

Mr Richard Johanson
Scientific

North Staffs Maternity Hospital
Hilton Road
Staffordshire
Stoke-on-Trent
ST4 6SD
United Kingdom

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesAudit the number of uncomplicated breech pregnancies at term being offered External Cephalic Version (ECV) and evaluate the impact of providing a multifaceted intervention package on patient management in terms of eligible women being offered ECV.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreech presentation birth
Intervention1. ECV
2. No ECV
Intervention typeOther
Primary outcome measureAdded 28/01/10:
The percentage of women with breech presentation at term who were offered ECV in the antenatal clinic, before and after the intervention
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/1995
Completion date01/08/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants20 consultant-based maternity units (added 28/01/10; see publication)
Key inclusion criteriaPregnant females with uncomplicated breech birth
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/08/1995
Date of final enrolment01/08/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North Staffs Maternity Hospital
Stoke-on-Trent
ST4 6SD
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 West Midlands (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 10/12/2001 Yes No