Atosiban versus fenoterol as a uterine relaxant for external cephalic version: Randomised controlled trial

Joost Velzel, Floortje Vlemmix, Brent C. Opmeer, Jan F M Molkenboer, Corine J. Verhoeven, Mariëlle G. Van Pampus, Dimitri N M Papatsonis, Joke M J Bais, Karlijn C. Vollebregt, Liesbeth Van Der Esch, Joris A M Van Der Post, Ben Willem Mol, Marjolein Kok

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objective To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation. Design Multicentre, open label, randomised controlled trial. Setting Eight hospitals in the Netherlands, August 2009 to May 2014. Participants 830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 μg fenoterol (n=414) intravenously for uterine relaxation before ECV. Main outcome measures The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis. Results Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34% v 40%, relative risk 0.73, 95% confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35% (n=139) of the atosiban group and 40% (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60% (n=240) of women in the atosiban group and 55% (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events. Conclusions In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.

LanguageEnglish
Article numberi6773
JournalBMJ (Online)
Volume356
DOIs
Publication statusPublished - 1 Jan 2017

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Velzel, J., Vlemmix, F., Opmeer, B. C., Molkenboer, J. F. M., Verhoeven, C. J., Van Pampus, M. G., ... Kok, M. (2017). Atosiban versus fenoterol as a uterine relaxant for external cephalic version: Randomised controlled trial. BMJ (Online), 356, [i6773]. https://doi.org/10.1136/bmj.i6773
Velzel, Joost ; Vlemmix, Floortje ; Opmeer, Brent C. ; Molkenboer, Jan F M ; Verhoeven, Corine J. ; Van Pampus, Mariëlle G. ; Papatsonis, Dimitri N M ; Bais, Joke M J ; Vollebregt, Karlijn C. ; Van Der Esch, Liesbeth ; Van Der Post, Joris A M ; Mol, Ben Willem ; Kok, Marjolein. / Atosiban versus fenoterol as a uterine relaxant for external cephalic version : Randomised controlled trial. In: BMJ (Online). 2017 ; Vol. 356.
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abstract = "Objective To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation. Design Multicentre, open label, randomised controlled trial. Setting Eight hospitals in the Netherlands, August 2009 to May 2014. Participants 830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 μg fenoterol (n=414) intravenously for uterine relaxation before ECV. Main outcome measures The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis. Results Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34{\%} v 40{\%}, relative risk 0.73, 95{\%} confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35{\%} (n=139) of the atosiban group and 40{\%} (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60{\%} (n=240) of women in the atosiban group and 55{\%} (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events. Conclusions In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.",
author = "Joost Velzel and Floortje Vlemmix and Opmeer, {Brent C.} and Molkenboer, {Jan F M} and Verhoeven, {Corine J.} and {Van Pampus}, {Mari{\"e}lle G.} and Papatsonis, {Dimitri N M} and Bais, {Joke M J} and Vollebregt, {Karlijn C.} and {Van Der Esch}, Liesbeth and {Van Der Post}, {Joris A M} and Mol, {Ben Willem} and Marjolein Kok",
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Velzel, J, Vlemmix, F, Opmeer, BC, Molkenboer, JFM, Verhoeven, CJ, Van Pampus, MG, Papatsonis, DNM, Bais, JMJ, Vollebregt, KC, Van Der Esch, L, Van Der Post, JAM, Mol, BW & Kok, M 2017, 'Atosiban versus fenoterol as a uterine relaxant for external cephalic version: Randomised controlled trial', BMJ (Online), vol. 356, i6773. https://doi.org/10.1136/bmj.i6773

Atosiban versus fenoterol as a uterine relaxant for external cephalic version : Randomised controlled trial. / Velzel, Joost; Vlemmix, Floortje; Opmeer, Brent C.; Molkenboer, Jan F M; Verhoeven, Corine J.; Van Pampus, Mariëlle G.; Papatsonis, Dimitri N M; Bais, Joke M J; Vollebregt, Karlijn C.; Van Der Esch, Liesbeth; Van Der Post, Joris A M; Mol, Ben Willem; Kok, Marjolein.

In: BMJ (Online), Vol. 356, i6773, 01.01.2017.

Research output: Contribution to journalArticle

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T1 - Atosiban versus fenoterol as a uterine relaxant for external cephalic version

T2 - BMJ (Online)

AU - Velzel, Joost

AU - Vlemmix, Floortje

AU - Opmeer, Brent C.

AU - Molkenboer, Jan F M

AU - Verhoeven, Corine J.

AU - Van Pampus, Mariëlle G.

AU - Papatsonis, Dimitri N M

AU - Bais, Joke M J

AU - Vollebregt, Karlijn C.

AU - Van Der Esch, Liesbeth

AU - Van Der Post, Joris A M

AU - Mol, Ben Willem

AU - Kok, Marjolein

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N2 - Objective To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation. Design Multicentre, open label, randomised controlled trial. Setting Eight hospitals in the Netherlands, August 2009 to May 2014. Participants 830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 μg fenoterol (n=414) intravenously for uterine relaxation before ECV. Main outcome measures The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis. Results Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34% v 40%, relative risk 0.73, 95% confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35% (n=139) of the atosiban group and 40% (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60% (n=240) of women in the atosiban group and 55% (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events. Conclusions In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.

AB - Objective To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation. Design Multicentre, open label, randomised controlled trial. Setting Eight hospitals in the Netherlands, August 2009 to May 2014. Participants 830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 μg fenoterol (n=414) intravenously for uterine relaxation before ECV. Main outcome measures The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis. Results Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34% v 40%, relative risk 0.73, 95% confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35% (n=139) of the atosiban group and 40% (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60% (n=240) of women in the atosiban group and 55% (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events. Conclusions In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.

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Velzel J, Vlemmix F, Opmeer BC, Molkenboer JFM, Verhoeven CJ, Van Pampus MG et al. Atosiban versus fenoterol as a uterine relaxant for external cephalic version: Randomised controlled trial. BMJ (Online). 2017 Jan 1;356. i6773. https://doi.org/10.1136/bmj.i6773