Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
672.21
Study information
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
Acronym
TORSION STUDY
Study hypothesis
A larger terbutaline dose will provide more effective tocolysis resulting in a higher rate of successful external cephalic version.
Ethics approval
University of Malaya Medical Centre Medical Ethics Committee gave approval on the 27th August 2008 (ref: 672.21)
Study design
Double blind randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Terbutaline
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
27/08/2008
Overall trial end date
28/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
At least 104 women
Participant 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
Recruitment start date
27/08/2008
Recruitment end date
28/02/2010
Locations
Countries of recruitment
Malaysia
Trial participating centre
Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre (Malaysia)
Sponsor details
Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia)
Alternative name(s)
Ministry of Land and Resources, UM
Funding Body Type
unknown
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
Basic results (scientific)
Publication list