Misoprostol in Addition to a Double-Balloon Catheter for Induction: A Double-Blind Randomized Controlled TrialFunding None.
10 May 2017
09 August 2017
14 September 2017 (eFirst)
Objective This article aims to evaluate whether the use of a double-balloon catheter with oral misoprostol results in a lower rate of cesarean and shorter times to delivery than the use of the double-balloon catheter with oral placebo.
Study Design In a double-blind randomized controlled trial, a double-balloon catheter was used for induction of labor with two doses of either 50 µg of misoprostol or placebo. Outcomes included cesarean rate, time to vaginal delivery, change in Bishop's score, and oxytocin usage.
Results A total of 343 women were screened and 199 randomized: 99 to the misoprostol arm and 100 to the placebo arm. Cesarean delivery rate was not different between the groups (misoprostol: 13.1% vs. placebo: 17.0%, p = 0.45). Time to vaginal delivery was significantly shorter (mean: 14.6 ± 6.9 vs. 20.8 ± 13.8 hours, p < 0.0001), change in Bishop's score was significantly greater (median: 5 vs. 4 points, p = 0.005), and use of oxytocin was significantly less frequent (86.9 vs. 98.0% patients, p = 0.01) in the misoprostol group.
Conclusion The use of a double-balloon catheter with oral misoprostol for induction did not reduce the cesarean delivery rate, but did result in shorter labors, a greater increase in Bishop's score, and a lower need for oxytocin use.
Keywordsinduction of labor - misoprostol - double-balloon catheter - cesarean delivery rate - Bishop's score
This is a double-blind randomized controlled trial performed at a single institution. Lili Zhou, MS, with the Department of Pharmacology, University of Arizona, Tucson, Arizona provided assistance with statistical analysis for this study. Cook Medical provided 200 Cook Cervical Ripening Balloons for use in this study.
- 1 Martin JA, Hamilton BE, Sutton PD, Ventura SJ. , et al. Births: final data for 2006. Natl Vital Stat Rep 2009; 57 (07) 1-104
- 2 Boyle A, Reddy UM. Epidemiology of cesarean delivery: the scope of the problem. Semin Perinatol 2012; 36 (05) 308-314
- 3 Centers for Disease Control and Prevention (CDC). Rates of cesarean delivery--United States, 1991. Morb Mortal Wkly Rep 1993; 42 (15) 285-289
- 4 Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2007. Natl Vital Stat Rep 2009; 57 (12) 1-23
- 5 Zhang J, Landy HJ, Branch DW. , et al; Consortium on Safe Labor. Contemporary patterns of spontaneous labor with normal neonatal outcomes. Obstet Gynecol 2010; 116 (06) 1281-1287
- 6 Zhang J, Troendle JF, Yancey MK. Reassessing the labor curve in nulliparous women. Am J Obstet Gynecol 2002; 187 (04) 824-828
- 7 Jozwiak M, Oude Rengerink K, Benthem M. , et al; PROBAAT Study Group. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. Lancet 2011; 378 (9809): 2095-2103
- 8 Abramovici D, Goldwasser S, Mabie BC, Mercer BM, Goldwasser R, Sibai BM. A randomized comparison of oral misoprostol versus Foley catheter and oxytocin for induction of labor at term. Am J Obstet Gynecol 1999; 181 (5, Pt 1): 1108-1112
- 9 Sciscione AC, Nguyen L, Manley J, Pollock M, Maas B, Colmorgen G. A randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening. Obstet Gynecol 2001; 97 (04) 603-607
- 10 Delaney S, Shaffer BL, Cheng YW. , et al. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol 2010; 115 (06) 1239-1245
- 11 Levy R, Kanengiser B, Furman B, Ben Arie A, Brown D, Hagay ZJ. A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening. Am J Obstet Gynecol 2004; 191 (05) 1632-1636
- 12 Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Am J Obstet Gynecol 2003; 189 (04) 1031-1035
- 13 Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol 2013; 121 (2, Pt 1): 247-252
- 14 Salim R, Zafran N, Nachum Z, Garmi G, Kraiem N, Shalev E. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial. Obstet Gynecol 2011; 118 (01) 79-86
- 15 Du C, Liu Y, Liu Y, Ding H, Zhang R, Tan J. Double-balloon catheter vs. dinoprostone vaginal insert for induction of labor with an unfavorable cervix. Arch Gynecol Obstet 2015; 291 (06) 1221-1227
- 16 Knol MJ, Duijnhoven RG, Grobbee DE, Moons KG, Groenwold RH. Potential misinterpretation of treatment effects due to use of odds ratios and logistic regression in randomized controlled trials. PLoS One 2011; 6 (06) e21248
- 17 Maslovitz S, Lessing JB, Many A. Complications of trans-cervical Foley catheter for labor induction among 1,083 women. Arch Gynecol Obstet 2010; 281 (03) 473-477