Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial.
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).


CONCLUSIONS
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.
Kok
Marjolein
M
Departments of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam; Medical Centre Alkmaar, Alkmaar, the Netherlands. mkok@amc.uva.nl
Bais
Joke M
JM
van Lith
Jan M
JM
Papatsonis
Dimitri M
DM
Kleiverda
Gunilla
G
Hanny
Dahrs
D
Doornbos
Johannes P
JP
Mol
Ben W
BW
van der Post
Joris A
JA
D000328:Adult; D001946:Breech Presentation / Q000601:surgery*; D002585:Cesarean Section / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D009543:Nifedipine / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D011247:Pregnancy; D015149:Tocolytic Agents / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D014599:Uterus / Q000187:drug effects*; D014710:Version, Fetal / Q000379:methods
D015149:Tocolytic Agents; D009543:Nifedipine