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RCT Results: Can Outpatient Cervical Ripening with Foley Decrease Time from Admission to Delivery?

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BACKGROUND AND PURPOSE:

  • Ausbeck et al. (Obstetrics & Gynecology, 2020) examined whether outpatient Foley catheter cervical ripening in nulliparous women shortens the time from admission to delivery

METHODS:

  • Randomized controlled trial
  • Participants
    • Singleton pregnancies
    • Nulliparous
    • Elective labor induction at ≥39 weeks
    • Modified Bishop score <5
  • Intervention
    • Outpatient transcervical Foley
      • Inserted the day before admission for scheduled induction
    • Inpatient transcervical Foley
      • Inserted at scheduled admission
  • Power analysis
    • 126 participants (63 in each group) required to detect at least a 5-hour mean difference in the primary outcome
    • 80% power | Two-sided alpha of 0.05
  • Primary outcome
    • Duration of time from admission to delivery

RESULTS:

  • 126 participants, 63 in each group
    • Baseline characteristics were balanced between the two groups, except that the following were lower in the outpatient group
      • BMI: 31±5.4 vs 34±7.5 (P=.01)
      • Group B streptococcus colonization: 31% vs 54% (P=.01)
  • The time from admission to delivery was shorter in the outpatient group
    • Outpatient: 17.4±7.4 hours
    • Inpatient: 21.7±9.1 hours
    • Mean difference 4.3 hours (95% CI 1.3 to 7.2); P<0.01
  • Admissions before scheduled induction were higher in the outpatient group
    • Outpatient: 22%
    • Inpatient: 5%
    • Relative risk 4.7 (95% CI 1.4 to 15.4); P<0.01
  • Median modified Bishop score on admission was also higher in the outpatient group (P<0.01)
    • Outpatient: score of 3
    • Inpatient: score of 1
  • There was no significant difference in
    • Cesarean delivery (P=0.32)
      • Outpatient: 24%
      • Inpatient: 32%
      • RR 0.8 (95% CI 0.4 to 1.3)
    • Chorioamnionitis (P=0.16)
      • Outpatient: 22%
      • Inpatient: 13%
      • RR 1.8 (95% CI 0.8 to 3.9)

CONCLUSION:

  • Outpatient Foley catheter for cervical ripening decreased time from admission to delivery for nulliparous women undergoing elective labor induction at term
  • The authors do caution that

Larger studies are needed to evaluate cesarean delivery, infection, and other safety outcomes

Learn More – Primary Sources:

Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial

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Related ObG Topics:

Cochrane Review 2017: Outpatient Cervical Ripening and Labor Induction
Does Outpatient Foley Catheter Hasten Time to Delivery in Parous Women?
RCT Results: Outpatient Balloon Catheter vs Inpatient Prostaglandin E2 for Induction of Labor

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