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

Completed

• Conditions: Breech presentation at term; Pregnancy and Childbirth; Other assisted single delivery

• Registration Number: ISRCTN89932581
• Lead Sponsor: niversity of Malaya Medical Centre (Malaysia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 104

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Immediate success rate of external cephalic version (ECV)<br>2. Caesarean delivery rate<br>3. Cephalic presentation at birth<br><br>All determined by no later than at the birth of the baby.

Secondary Outcome Measures

Name	Time	Method
1. Post-ECV cardiotocograph abnormalities<br>2. Neonatal outcomes:<br>2.1. Neonatal nursery admission<br>2.2. Apgar score at 5 minutes<br>2.3. Umbilical cord arterial blood, pH<br>3. Adverse drug events<br>4. Visual Analog Scale (VAS) satisfaction score with ECV<br>5. Indication for operative delivery<br><br>Determined by no later than hospital discharge following birth.