Oral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: a double-blind randomised trial.

OBJECTIVE: To evaluate oral nifedipine versus subcutaneous terbutaline tocolysis for external cephalic version (ECV).

DESIGN: A double-blind randomised trial.

SETTING: A university hospital in Malaysia.

POPULATION: Non-labouring women with a term singleton fetus in breech presentation or transverse lie suitable for elective ECV.

METHODS: Participants were randomised to either 10 mg oral nifedipine tablet and subcutaneous saline placebo or oral placebo tablet and 250 microgram bolus terbutaline subcutaneously. Participants and providers were blinded. Ultrasound assessment and cardiotocogram were performed prior to ECV. ECV was commenced 20-30 minutes after treatment. A maximum of two ECV attempts were permitted. Elective caesarean delivery or a repeat ECV attempt at a later date was offered to participants following failed ECV. After successful ECV, management was expectant.

MAIN OUTCOME MEASURES: Primary outcomes were successful ECV (cephalic presentation immediately after ECV) and caesarean delivery.

RESULTS: Ninety women were randomised: 44 to nifedipine and 46 to terbutaline. Initial ECV success rate was 15/44 (34.1%) versus 24/46 (52.2%) (relative risk [RR] 0.7, 95% CI 0.4-1.1; P= 0.094), and caesarean delivery rate was 34/44 (77.3%) versus 26/46 (56.5%) (RR 1.4, 95% CI 1.01-1.85; numbers needed to treat to benefit 5, 95% CI 2.5-55; P= 0.046) for nifedipine and terbutaline groups, respectively. Neonatal outcome was not different.

CONCLUSIONS: Bolus subcutaneous terbutaline tocolysis for ECV compared with oral nifedipine resulted in less caesarean deliveries. ECV success rate was not significantly higher. Larger studies are indicated.