A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter

Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.

Abstract

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 ≤6 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravaginal
  • Adult
  • Analgesia, Epidural / statistics & numerical data
  • Catheterization*
  • Cervical Ripening*
  • Cesarean Section / statistics & numerical data
  • Delivery, Obstetric / statistics & numerical data
  • Dinoprostone / therapeutic use*
  • Drug Utilization / statistics & numerical data
  • Female
  • Humans
  • Labor, Induced / instrumentation
  • Labor, Induced / methods*
  • Length of Stay / statistics & numerical data
  • Middle Aged
  • Muscle Hypertonia / etiology
  • Oxytocics / therapeutic use*
  • Oxytocin / therapeutic use
  • Postpartum Hemorrhage / epidemiology
  • Pregnancy
  • Time Factors
  • Uterine Contraction
  • Young Adult

Substances

  • Oxytocics
  • Oxytocin
  • Dinoprostone