Prospective multi-centre randomised trial comparing induction of labour with a double-balloon catheter versus dinoprostone

Abstract

This randomised controlled study compared the efficacy of double-balloon catheter versus vaginal prostaglandin E2 (dinoprostone) for induction of labour. In total, 825 pregnant women with cephalic presentation and an unfavourable cervix undergoing induction for conventional indications were randomised to double-balloon or vaginal dinoprostone (3 mg) groups. There was a significantly higher failure rate for labour induction in the balloon group (relative risk: 1.25, 95% confidence interval [CI]: 1.02–1.49). Median induction time was 27.3 h in the balloon group and 29.8 h in the dinoprostone group (difference not significant). After 24 h, 55.3% had given birth in the balloon group versus 54.3% in the dinoprostone group. Additional oxytocin stimulation was used more often in the balloon (46%) compared with that in the dinoprostone (34%) (relative risk: 1.34 (95%CI 1.16 –1.54) group. Caesarean section rates and neonatal outcome were similar. Overall, the two methods for induction were comparable with regard to efficacy and safety.

Keywords::

• Induction of labour
• double-balloon catheter
• mechanical ripening
• balloon catheter
• prostaglandin
• dinoprostone

Acknowledgements

We would like to thank all the women who volunteered to participate and the staff at the labour wards who enrolled the participants. We would also like to thank Birgit Bødker, Hillerød Hospital; Inge Marie Rasmussen, Frederiksberg Hospital; Lisbeth Jønsson, Næstved Hospital; Pia Damgaard, midwife; Tine Teschzner, Rigshospitalet; Jette Seidelin, Hvidovre Hospital; and Ole Jørgensen, Svendborg Hospital for their invaluable collaboration in the conduction and surveillance of the study, which took place in their labour wards and included their patients.

Declaration of interest: None of the authors have any competing interests to report. The randomisation procedure was funded by ‘Snedkermester Sophus Jacobsen & Astrid Jacobsens fond’ and the Danish Toyota Foundation.

HN, ML, HBP and IC initiated and designed the investigation. EL, MM and HN collected and analysed the data. EL wrote the manuscript. IJC performed statistical analyses. All participants performed critical revision of the manuscript.