BACKGROUND AND PURPOSE:

• Nasioudis et al. (AJOG MFM, 2019) assessed the efficacy and safety of combined methods of cervical ripening vs misoprostol only

METHODS:

• Systematic review and meta-analysis
• Data sources
  • Medline, EMBASE, and Web-of-Science electronic databases (through to December, 2018)
• Study inclusion criteria
  • RCTs
  • Singleton, viable fetus
  • IOL that required cervical ripening (Bishop ≤7)
    • (1) Single balloon Foley catheter combined with misoprostol (any dose or route) or (2) misoprostol only
• Data synthesis and analysis
  • Data pooled using random effects and fixed effects model
  • Bias criteria based on Cochrane Handbook for Systematic Reviews of Interventions
• Primary outcomes
  • Time to delivery
  • Rate of cesarean delivery

RESULTS:

• 11 trials | 922 subjects in the combination group | 947 patients in the misoprostol-only group
  • Majority of misoprostol was administered via vaginal route
• There was no difference in the rate of cesarean delivery between the 2 groups
  • Relative risk (RR): 0.95 (95% CI, 0.80 to 1.13)
• Combination of mechanical dilation and misoprostol resulted in
  • Shorter time to delivery
    • Mean difference: –3.65 hours (95% CI, 5.23 to –2.07)
  • Shorter time to vaginal delivery
    • Mean difference: –4.53 hours (95% CI, –5.79 to –3.27)
  • Lower risk of NICU admission
    • RR: 0.71 (95% CI, 0.53 to 0.96)
  • Meconium-stained fluid
    • RR: 0.62 (95% CI, 0.43 to 0.90)
  • Tachysystole with fetal heart trace changes
    • RR: 0.53 (95% CI, 0.30 to 0.94)
  • Terbutaline use
    • RR: 0.63 (95% CI, 0.47 to 0.85)
• Exclusion of preterm patients led to a greater benefit using combination with respect to NICU admission
  • RR: 0.61 (95% CI, 0.40 to 0.93)
• Risk of endometritis and chorioamnionitis was similar between groups
  • Endometritis: RR 1.07 (95% CI, 0.43 to 2.61)
  • Chorioamnionitis: RR 1.58 (95% CI, 0.88 to 2.84)

CONCLUSION:

• Misoprostol use with mechanical dilation is safe and effective and compared to misoprostol alone is associated with
  • Shorter delivery time | No difference in cesarean rates | Decreased NICU admission rates
• AJOG MFM Editor’s Note

This is a practice-changing manuscript, if you have not changed your practice yet in terms of using a double-agent for cervical ripening to start induction of labor.

Using either balloon alone, or misoprostol alone, unless one of the agents is either not insertable or contraindicated, seems now like substandard care given these data.

If misoprostol is contraindicated, a balloon and oxytocin ‘double-agent’ combination can be used instead.

Learn More – Primary Sources:

Maternal and neonatal outcomes with mechanical cervical dilation plus misoprostol compared to misoprostol alone for cervical ripening; a systematic review of literature and metaanalysis

Related ObG Topics:

What is the Best Labor Induction Method for Multiparous Women?

Double-Balloon Catheter or Prostaglandin E2 for Cervical Ripening

Cochrane Review 2017: Outpatient Cervical Ripening and Labor Induction