Condition category
Pregnancy and Childbirth
Date applied
09/05/2009
Date assigned
13/05/2009
Last edited
13/05/2009
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 and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

672.21

Study information

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

Acronym

TORSION STUDY

Study hypothesis

A larger terbutaline dose will provide more effective tocolysis resulting in a higher rate of successful external cephalic version.

Ethics approval

University of Malaya Medical Centre Medical Ethics Committee gave approval on the 27th August 2008 (ref: 672.21)

Study design

Double blind randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Terbutaline

Primary outcome measures

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 trial start date

27/08/2008

Overall trial end date

28/02/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

At least 104 women

Participant 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

Recruitment start date

27/08/2008

Recruitment end date

28/02/2010

Locations

Countries of recruitment

Malaysia

Trial participating centre

Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya Medical Centre (Malaysia)

Sponsor details

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
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 (Malaysia)

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

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