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Objective
We sought to compare the efficacy of a double-balloon transcervical catheter to that of a prostaglandin (PG) vaginal insert among women undergoing labor induction.
Study Design
In all, 210 women with a Bishop score ¡Ü6 were assigned randomly to cervical ripening with either a double-balloon device or a PGE2 sustained-release vaginal insert. Primary outcome was vaginal delivery within 24 hours.
Results
The proportion of women who achieved vaginal delivery in 24 hours was higher in the double-balloon group than in the PGE2 group (68.6 % vs 49.5 % ; odds ratio, 2.22; 95 % confidence interval, 1.26-3.91). There was no difference in cesarean delivery rates (23.8 % vs 26.2 % ; odds ratio, 0.88; 95 % confidence interval, 0.47-1.65). Oxytocin and epidural analgesia were administered more frequently when a double-balloon device was used. Uterine tachysystole or hypertonus occurred more frequently in the PGE2 arm (9.7 % vs 0 % , P = .0007).
Conclusion
The use of a double-balloon catheter for cervical ripening is associated with a higher rate of vaginal birth within 24 hours compared with a PGE2 vaginal insert.
