Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
547
Study information
Scientific title
Acronym
Study hypothesis
Audit 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
Not provided at time of registration
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breech presentation birth
Intervention
1. ECV
2. No ECV
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Added 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 measures
Not provided at time of registration
Overall trial start date
01/08/1995
Overall trial end date
01/08/1997
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant females with uncomplicated breech birth
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
20 consultant-based maternity units (added 28/01/10; see publication)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/08/1995
Recruitment end date
01/08/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Staffs Maternity Hospital
Stoke-on-Trent
ST4 6SD
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 West Midlands (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
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11728654
Publication citations
-
Results
Burr R, Johanson R, Wyatt J, Watt I, Jones P, A randomised trial of an intervention package designed to promote external cephalic version at term., Eur. J. Obstet. Gynecol. Reprod. Biol., 2001, 100, 1, 36-40.