Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Jan 26:356:i6773.
doi: 10.1136/bmj.i6773.

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

Joost Velzel  1 , Floortje Vlemmix  2 , Brent C Opmeer  3 , Jan F M Molkenboer  4 , Corine J Verhoeven  5 , Mariëlle G van Pampus  6 , Dimitri N M Papatsonis  7 , Joke M J Bais  8 , Karlijn C Vollebregt  9 , Liesbeth van der Esch  10 , Joris A M Van der Post  2 , Ben Willem Mol  11   12 , Marjolein Kok  2
Affiliations
Randomized Controlled Trial

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

Joost Velzel et al. BMJ. .

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.

Trial registration: Dutch Trial Register, NTR 1877.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. BM is an advisor for ObsEva, Geneva, Switzerland.

Figures

None
Fig 1 Randomisation, treatment, and follow-up of participants
See this image and copyright information in PMC

References

    1. Hickok DE, Gordon DC, Milberg JA, Williams MA, Daling JR. The frequency of breech presentation by gestational age at birth: a large population-based study. Am J Obstet Gynecol 1992;166:851-2. 10.1016/0002-9378(92)91347-D pmid:1550152. - DOI - PubMed
    1. Rietberg CCT, Elferink-Stinkens PM, Visser GHA. The effect of the Term Breech Trial on medical intervention behaviour and neonatal outcome in The Netherlands: an analysis of 35,453 term breech infants. BJOG 2005;112:205-9. 10.1111/j.1471-0528.2004.00317.x pmid:15663585. - DOI - PubMed
    1. Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Term Breech Trial Collaborative Group. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Lancet 2000;356:1375-83. 10.1016/S0140-6736(00)02840-3 pmid:11052579. - DOI - PubMed
    1. Betran AP, Torloni MR, Zhang JJ, Gülmezoglu AM. WHO Working Group on Caesarean Section. WHO statement on caesarean section rates. BJOG 2016;123:667-70. 10.1111/1471-0528.13526. pmid:26681211. - DOI - PMC - PubMed
    1. Gibbons L, Belizan JM, Lauer JA, Betran AP, Merialdi M, Althabe F. Inequities in the use of cesarean section deliveries in the world. Am J Obstet Gynecol 2012;206:331.e1-19. 10.1016/j.ajog.2012.02.026 pmid:22464076. - DOI - PubMed

Publication types