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

Marjolein Kok, Joke M. Bais, Jan M. Van Lith, Dimitri M. Papatsonis, Gunilla Kleiverda, Dahrs Hanny, Johannes P. Doornbos, Ben W. Mol, Joris A. Van Der Post

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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.

LanguageEnglish
Pages271-276
Number of pages6
JournalObstetrics and Gynecology
Volume112
Issue number2
DOIs
Publication statusPublished - 1 Jan 2008

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Kok, M., Bais, J. M., Van Lith, J. M., Papatsonis, D. M., Kleiverda, G., Hanny, D., ... Van Der Post, J. A. (2008). Nifedipine as a uterine relaxant for external cephalic version: A randomized controlled trial. Obstetrics and Gynecology, 112(2), 271-276. https://doi.org/10.1097/AOG.0b013e31817f1f2e
Kok, Marjolein ; Bais, Joke M. ; Van Lith, Jan M. ; Papatsonis, Dimitri M. ; Kleiverda, Gunilla ; Hanny, Dahrs ; Doornbos, Johannes P. ; Mol, Ben W. ; Van Der Post, Joris A. / Nifedipine as a uterine relaxant for external cephalic version : A randomized controlled trial. In: Obstetrics and Gynecology. 2008 ; Vol. 112, No. 2. pp. 271-276.
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Kok, M, Bais, JM, Van Lith, JM, Papatsonis, DM, Kleiverda, G, Hanny, D, Doornbos, JP, Mol, BW & Van Der Post, JA 2008, 'Nifedipine as a uterine relaxant for external cephalic version: A randomized controlled trial', Obstetrics and Gynecology, vol. 112, no. 2, pp. 271-276. https://doi.org/10.1097/AOG.0b013e31817f1f2e

Nifedipine as a uterine relaxant for external cephalic version : A randomized controlled trial. / Kok, Marjolein; Bais, Joke M.; Van Lith, Jan M.; Papatsonis, Dimitri M.; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P.; Mol, Ben W.; Van Der Post, Joris A.

In: Obstetrics and Gynecology, Vol. 112, No. 2, 01.01.2008, p. 271-276.

Research output: Contribution to journalArticle

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AU - Kok, Marjolein

AU - Bais, Joke M.

AU - Van Lith, Jan M.

AU - Papatsonis, Dimitri M.

AU - Kleiverda, Gunilla

AU - Hanny, Dahrs

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AU - Mol, Ben W.

AU - Van Der Post, Joris A.

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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.

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