External Cephalic Version (ECV) Tocolysis Trial: Oral nifedipine vs subcutaneous terbutaline
ISRCTN | ISRCTN14802064 |
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DOI | https://doi.org/10.1186/ISRCTN14802064 |
Secondary identifying numbers | 459.5 |
- Submission date
- 15/07/2008
- Registration date
- 31/07/2008
- Last edited
- 31/07/2008
- 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 & Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Study information
Study design | Randomised, double-blind trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
Scientific title | Oral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: A double blind randomised trial |
Study acronym | STONE Trial |
Study objectives | Oral nifedipine is comparable to subcutaneous terbutaline as tocolysis for external cephalic version |
Ethics approval(s) | University of Malaya Medical Centre, Medical Ethics Committee. Date of approval: 17/08/2005 (ref: 459.5) |
Health condition(s) or problem(s) studied | Breech presentation at term gestation |
Intervention | Participants were randomised to treatment with 10 milligram oral nifedipine tablet and subcutaneous saline placebo injection or oral placebo tablet and subcutaneous 250 microgram terbutaline injection administered 20-30 minutes before commencing external cephalic version. |
Intervention type | Other |
Primary outcome measure | 1. Successful version to cephalic presentation 2. Caesarean delivery |
Secondary outcome measures | 1. Cephalic presentation at birth 2. Post-ECV cardiotocographic anomalies 3. Visual analogue scale satisfaction score with ECV procedure 4. Onset of labour 5. Neonatal outcome 6. Survey on patient preference of oral vs injection mode of medication 7. Maternal peri-delivery blood loss 8. Indication for operative delivery 9. Adverse drug events |
Overall study start date | 01/12/2005 |
Completion date | 01/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 90 |
Key inclusion criteria | 1. Breech presentation or transverse lie 2. Viable, singleton pregnancy 3. Gestation age 36 to 41 weeks 4. Intact membranes 5. Not in established labour |
Key exclusion criteria | 1. Known gross foetal anomaly 2. Severe hypertension 3. Intrauterine growth restriction 4. Oligohydramnios 5. Antepartum haemorrhage within last 3 months 6. Uterine scar from any source 7. Known allergy to nifedipine or terbutaline 8. Other potential obstetric indication for Caesarean delivery 8.1. Placenta praevia 8.2. Suspected macrosomia >4 kg 8.3. Uterine anomaly 8.4. Obstructive pelvic tumour |
Date of first enrolment | 01/12/2005 |
Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia
50603
Malaysia
Sponsor information
University of Malaya Medical Centre (Malaysia)
University/education
University/education
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Website | http://www.ummc.edu.my |
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https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
University of Malaya, Department of Obstetrics and Gynaecology (Malaysia)
No information available
Results and Publications
Intention to publish date | |
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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 |