TY - JOUR
T1 - Nifedipine as a uterine relaxant for external cephalic version
T2 - A randomized controlled trial
AU - Kok, Marjolein
AU - Bais, Joke M.
AU - van Lith, Jan M.
AU - Papatsonis, Dimitri M.
AU - Kleiverda, Gunilla
AU - Hanny, Dahrs
AU - Doornbos, Johannes P.
AU - Mol, Ben W.
AU - van der Post, Joris A.
PY - 2008/1/1
Y1 - 2008/1/1
N2 - To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. 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. 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). 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. Current Controlled Trials, , ISRCTN 28715121 I.
AB - To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. 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. 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). 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. Current Controlled Trials, , ISRCTN 28715121 I.
UR - http://www.scopus.com/inward/record.url?scp=51649098578&partnerID=8YFLogxK
U2 - 10.1097/AOG.0b013e31817f1f2e
DO - 10.1097/AOG.0b013e31817f1f2e
M3 - Article
C2 - 18669722
AN - SCOPUS:51649098578
SN - 0029-7844
VL - 112
SP - 271
EP - 276
JO - Obstetrics & Gynecology
JF - Obstetrics & Gynecology
IS - 2
ER -