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Nifedipine as a Uterine Relaxant for External Cephalic Version: A Randomized Controlled Trial.

Author(s): Kok M, Bais JM, van Lith JM, Papatsonis DM, Kleiverda G, Hanny D, Doornbos JP, Mol BW, van der Post JA

Affiliation(s): Departments of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam; Medical Centre Alkmaar, Alkmaar; Onze Lieve Vrouwe Gasthuis, Amsterdam; Amphia Hospital, Breda; Flevo Hospital, Almere; Spaarne Hospital, Hoofddorp; and Zaans Medical Centre, Zaandam, the Netherlands.

Publication date & source: 2008-08, Obstet Gynecol., 112(2):271-276.

OBJECTIVE: To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. METHODS: In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or more were eligible for enrollment. Participating women received two doses of either nifedipine 10 mg or placebo, 30 and 15 minutes before the external cephalic version attempt. The primary outcome was a cephalic-presenting fetus immediately after the procedure. Secondary outcome measures were cephalic presentation at delivery, mode of delivery, and adverse events. A sample size of 292 was calculated to provide 80% power to detect a 17% improvement of the external cephalic version success rate, assuming a placebo group rate of 40% and alpha of .05. RESULTS: Outcome data for 310 of 320 randomly assigned participants revealed no significant difference in external cephalic version success rates between treatment (42%) and control group (37%) (relative risk 1.1, 95%; 95% confidence interval 0.85-1.5). The cesarean delivery rate was 51% in the treatment group and 46% in the control group (relative risk 1.1, 95% confidence interval 0.88-1.4). CONCLUSION: Nifedipine did not significantly improve the success of external cephalic version. Future use of nifedipine to improve the outcome of external cephalic version should be limited to large clinical trials. CLINICAL TRIAL REGISTRATION: Current Controlled Trials, http://isrctn.org, ISRCTN 28715121 LEVEL OF EVIDENCE: I.

Page last updated: 2008-08-10

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