Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
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 Lawrence Impey

ORCID ID

Contact details

Level 4
The Women's Centre
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865741166 Ex 21408/21624
LWMI@compuserve.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SEO093

Study information

Scientific title

Acronym

Study hypothesis

To determine the optimum protocol for performing external cephalic version for breech presentation at term. Null hypothesis: that tocolysis for a repeat external cephalic version (ECV) after a failed ECV does not increase the success rates of ECV

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Childbirth

Intervention

1. 50 mg ritodrine hydrochloride infusion
2. 17 ml dextrose saline solution infusion

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Incidence of cephalic presentation at delivery
2. Subjective patient assessment of discomfort
3. Incidence of caesarian section
4. Length of hospital stay
5. Incidence of neonatal Apgar scores <7 at 5 minutes
6. Incidence of neonatal intensive care admission

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/04/2000

Overall trial end date

06/04/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with suspected or confirmed breech presentation at >36 weeks gestation
2. Have undergone a single (<15 mins) unsuccessful attempt at external cephalic version without tocolysis at 37 or more weeks' gestation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

124 (added 12/01/10, see publication)

Participant exclusion criteria

1. Abnormal cardiotocograph
2. Cardiac disease
3. Pre-existing or gestational diabetes
4. Hypertension;
5. Pre-existing indication for caesarian section
6. Suspected unstable lie
7. Pre-eclampsia
8. recent (<4 weeks) antepartum haemorrhage
9. suspected fetal compromise
10. rhesus immunisation

Recruitment start date

06/04/2000

Recruitment end date

06/04/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 4
Oxford
OX3 9DU
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 South East (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15842288

Publication citations

  1. Results

    Impey L, Pandit M, Tocolysis for repeat external cephalic version in breech presentation at term: a randomised, double-blinded, placebo-controlled trial., BJOG, 2005, 112, 5, 627-631, doi: 10.1111/j.1471-0528.2004.00518.x.

Additional files

Editorial Notes