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
Protocol serial number	SEO093
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Childbirth
Intervention	1. 50 mg ritodrine hydrochloride infusion 2. 17 ml dextrose saline solution infusion
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	06/04/2002

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	124
Key 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
Key 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
Date of first enrolment	06/04/2000
Date of final enrolment	06/04/2002

Level 4

Oxford
OX3 9DU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2005		Yes	No