Terbutaline tocolysis for external cephalic version: a randomised comparison of the 250 µg versus 500 µg bolus dose

ISRCTN	ISRCTN89932581
DOI	https://doi.org/10.1186/ISRCTN89932581
Protocol serial number	672.21
Sponsor	University of Malaya Medical Centre (Malaysia)
Funder	University of Malaya (Malaysia)

Submission date: 09/05/2009
Registration date: 13/05/2009
Last edited: 13/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peng Chiong Tan
Scientific

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Study information

Primary study design	Interventional
Study design	Double blind randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A double-blind randomised trial of 250 µg versus 500 µg bolus dose of terbutaline as a tocolytic agent in external cephalic version
Study acronym	TORSION STUDY
Study objectives	A larger terbutaline dose will provide more effective tocolysis resulting in a higher rate of successful external cephalic version.
Ethics approval(s)	University of Malaya Medical Centre Medical Ethics Committee gave approval on the 27th August 2008 (ref: 672.21)
Health condition(s) or problem(s) studied	Breech presentation at term
Intervention	Women are randomised to 250 µg or 500 µg of bolus subcutaneous terbutaline followed by external cephalic version 15 minutes later with a maximum of two attempts.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Terbutaline
Primary outcome measure(s)	1. Immediate success rate of external cephalic version (ECV) 2. Caesarean delivery rate 3. Cephalic presentation at birth All determined by no later than at the birth of the baby.
Key secondary outcome measure(s)	1. Post-ECV cardiotocograph abnormalities 2. Neonatal outcomes: 2.1. Neonatal nursery admission 2.2. Apgar score at 5 minutes 2.3. Umbilical cord arterial blood, pH 3. Adverse drug events 4. Visual Analog Scale (VAS) satisfaction score with ECV 5. Indication for operative delivery Determined by no later than hospital discharge following birth.
Completion date	28/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	104
Key inclusion criteria	1. Non-cephalic presentation 2. Singleton pregnancy 3. Gestation greater than or equal to 36 weeks (check for early confirmation of gestational age) 4. Intact membranes 5. Reassuring foetal status on cardiotocograph
Key exclusion criteria	1. Known gross foetal anomaly 2. Severe hypertension (greater than or equal to 160/110 mmHg or confirmed pre-eclampsia) 3. Growth restricted foetus (estimated foetal weight less than 2 kg or ultrasound-derived foetal abdominal circumference less than 10 centile on our chart) 4. Oligohydramnios (amniotic fluid index [AFI] less than 5) 5. Antepartum haemorrhage within last 7 days 6. Uterine scar from any source 7. Known allergy to terbutaline 8. Other potential obstetric indication for caesarean delivery: 8.1. Placenta praevia 8.2. Suspected macrosomia greater than 4 kg 8.3. Uterine anomaly (small fibroids not causing obstruction are acceptable) 8.4. Obstructive pelvic tumour
Date of first enrolment	27/08/2008
Date of final enrolment	28/02/2010

Locations

Countries of recruitment

Malaysia

Study participating centre

Department of Obstetrics and Gynaecology

Kuala Lumpur
50603
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes