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Terbutaline tocolysis for external cephalic version: a randomised comparison of the 250 µg versus 500 µg bolus dose

A double-blind randomised trial of 250 µg versus 500 µg bolus dose of terbutaline as a tocolytic agent in external cephalic version

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89932581
Enrollment
104
Registered
2009-05-13
Start date
2008-08-27
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech presentation at term Pregnancy and Childbirth Other assisted single delivery

Interventions

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.

Sponsors

University of Malaya Medical Centre (Malaysia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026