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
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
-
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.