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
Scientific
Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Study information
| Study design | Double blind randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 27/08/2008 |
| Completion date | 28/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | At least 104 women |
| 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
50603
Malaysia
Sponsor information
University of Malaya Medical Centre (Malaysia)
University/education
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" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
University of Malaya (Malaysia)
Government organisation / Universities (academic only)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
