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
Secondary identifying numbers 672.21
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

Study designDouble blind randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA double-blind randomised trial of 250 µg versus 500 µg bolus dose of terbutaline as a tocolytic agent in external cephalic version
Study acronymTORSION STUDY
Study objectivesA 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) studiedBreech presentation at term
InterventionWomen 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Terbutaline
Primary outcome measure1. 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 measures1. 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 study start date27/08/2008
Completion date28/02/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsAt least 104 women
Key inclusion criteria1. 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 criteria1. 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 enrolment27/08/2008
Date of final enrolment28/02/2010

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya Medical Centre (Malaysia)
University/education

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

Website http://www.ummc.edu.my/
ROR logo "ROR" https://ror.org/00vkrxq08

Funders

Funder type

University/education

University of Malaya (Malaysia)
Government organisation / Universities (academic only)
Alternative name(s)
University of Malaya, University Malaya, Malayan University, UM
Location
Malaysia

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