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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14802064
Enrollment
90
Registered
2008-07-31
Start date
2005-12-01
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 gestation Pregnancy and Childbirth Maternal care for known or suspected malpresentation of fetus

Interventions

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

Sponsors

University of Malaya Medical Centre (Malaysia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Successful version to cephalic presentation 2. Caesarean delivery

Secondary

MeasureTime frame
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

Countries

Malaysia

Outcome results

None listed

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