Randomised, double-blinded placebo controlled trial of the use of tocolysis for a repeat external cephalic version after a failed version for breech presentation at term

ISRCTN ISRCTN31614268
DOI https://doi.org/10.1186/ISRCTN31614268
Secondary identifying numbers SEO093
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
12/01/2010
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 Lawrence Impey
Scientific

Level 4
The Women's Centre
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Phone +44 (0)1865741166 Ex 21408/21624
Email LWMI@compuserve.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChildbirth
Intervention1. 50 mg ritodrine hydrochloride infusion
2. 17 ml dextrose saline solution infusion
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date06/04/2000
Completion date06/04/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants124 (added 12/01/10, see publication)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment06/04/2000
Date of final enrolment06/04/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Level 4
Oxford
OX3 9DU
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 South East (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 01/05/2005 Yes No