Condition category
Pregnancy and Childbirth
Date applied
15/07/2008
Date assigned
31/07/2008
Last edited
31/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peng Chiong Tan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

459.5

Study information

Scientific title

Oral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: A double blind randomised trial

Acronym

STONE Trial

Study hypothesis

Oral nifedipine is comparable to subcutaneous terbutaline as tocolysis for external cephalic version

Ethics approval

University of Malaya Medical Centre, Medical Ethics Committee. Date of approval: 17/08/2005 (ref: 459.5)

Study design

Randomised, double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/12/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

90

Participant 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

Recruitment start date

01/12/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Malaysia

Trial participating centre

Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya Medical Centre (Malaysia)

Sponsor details

Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor type

University/education

Website

http://www.ummc.edu.my

Funders

Funder type

University/education

Funder name

University of Malaya, Department of Obstetrics and Gynaecology (Malaysia)

Alternative name(s)

Funding Body Type

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes