Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/01/2010
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

Mr Richard Johanson

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes