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Grand Rounds

RCT Results: Does Early AROM Following Foley Expulsion Reduce Time to Delivery? 

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BACKGROUND AND PURPOSE: 

  • Gomez Slagle et al. (AJOG, 2022) evaluated whether amniotomy within 1 hour of Foley catheter expulsion reduces the duration of labor among individuals undergoing combined misoprostol and Foley catheter labor induction at term 

METHODS: 

  • Randomized clinical trial 
  • Participants 
    • Undergoing Foley catheter and misoprostol induction at ≥37 weeks  
    • Singleton
  • Interventions 
    • Early artificial rupture of membranes 
      • Amniotomy within 1 hour of Foley catheter expulsion 
    • Expectant management  
  • Study design  
    • Intent-to-treat strategy 
    • Adjustments: Age | BMI | Parity | Mode of delivery | Bishop score 
    • Interaction between randomization group and parity also analyzed  
  • Sample size  
    • Power 80% | Assuming 10% drop out, 160 patients to detect a 4-hour reduction in delivery time  
  • Primary outcome 
    • Time to delivery: Time from Foley catheter expulsion to delivery 

RESULTS: 

  • Early artificial rupture: 79 participants | Expectant management: 81 participants 
  • Early artificial rupture of membranes achieved a faster median time to delivery than expectant management (P<0.001) 
    • Early artificial rupture of membranes: 11.1 hours (IQR, 6.25 to 17.1) 
    • Expectant management: 19.8 hours (IQR, 13.2 to 26.2) 
  • In addition, a greater percentage of individuals in the early artificial rupture of membranes group delivered within 24 hours (P=0.03) 
    • Early artificial rupture of membranes: 86% 
    • Expectant management: 70% 
  • There was no difference in the cesarean delivery rate between the 2 groups (P=0.25) 
    • Early artificial rupture of membranes: 22% 
    • Expectant management: 31% 
  • Individuals delivered 2.3 times faster following early artificial rupture of membranes 
    • Hazard ratio 2.3 (95% CI, 1.5 to 3.4); P<0.001 
  • There were no significant differences in maternal or neonatal outcomes 

CONCLUSION: 

  • For women undergoing induction of labor, early artificial rupture of membranes within 1 hour of Foley catheter expulsion led to a 2.3 times faster time-to-delivery  
  • Study limitation includes lack of blinding  
    • However, time-to-delivery is an objective primary outcome measure  
  • The authors state 

Therefore, amniotomy within 1 hour of Foley catheter expulsion may be considered among individuals undergoing a combined pharmacologic and mechanical induction at term 

Learn More – Primary Sources: 

Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial 

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Related ObG Topics:

RCT Results: Balloon Catheter Removal at 6 vs 12 Hours and Time to Delivery
Does Adding a Foley to Misoprostol Decrease Time to Delivery?
Meta-Analysis: Does Outpatient Cervical Ripening with Balloon Catheter Decrease Time Spent on Labor and Delivery?
How Safe and Effective is Early Amniotomy During Labor Induction?

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