External Cephalic Version (ECV) Tocolysis Trial: Oral nifedipine vs subcutaneous terbutaline

ISRCTN ISRCTN14802064
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

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

Study information

Study designRandomised, double-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleOral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: A double blind randomised trial
Study acronymSTONE Trial
Study objectivesOral 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) studiedBreech presentation at term gestation
InterventionParticipants 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 typeOther
Primary outcome measure1. Successful version to cephalic presentation
2. Caesarean delivery
Secondary outcome measures1. 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 date01/12/2005
Completion date01/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants90
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2005
Date of final enrolment01/12/2007

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya Medical Centre (Malaysia)
University/education

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, Department of Obstetrics and Gynaecology (Malaysia)

No information available

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