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Grand Rounds

Does Adding a Foley to Misoprostol Decrease Time to Delivery?

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BACKGROUND AND PURPOSE:

  • Al-Ibraheemi et al. (Obstetrics & Gynecology, 2018) sought to determine whether concurrent misoprostol and transcervical Foley bulb leads to shorter time to delivery versus misoprostol alone

METHODS:

  • Randomized controlled trial (RCT)
  • Participants
    • Women admitted for cervical ripening ≥37 weeks
      • Singleton
      • Cephalic presentation
      • Bishop score ≤6
    • Exclusion
      • PROM | Regular uterine contractions | Prior uterine surgery | Malpresentation | Contraindication to prostaglandins | Nonreassuring FHR tracing | Vaginal bleeding, fetal demise | Anomalous fetus | Contraindication to vaginal delivery
    • Patients received either:
      • Misoprostol and transcervical Foley bulb
        • 30 cc bulb filled with 60 cc normal saline
        • If Foley expelled, follow-up management at discretion of the provider
      • Misoprostol alone
    • Misoprostol dose
      • 25 micrograms inserted vaginally into the posterior fornix every 4 hours
      • 100-microgram tablet cut into fourths by the hospital pharmacist
      • Repeat dosing up to a maximum of six doses (hospital protocol)
      • Discontinued if bishop score >6 or if the patient was in active labor (≥6 cm dilation) or no progress for 24 hours
    • Primary outcome: Time from placement of the misoprostol to delivery
    • Secondary outcomes
      • Time to active phase | Time from active phase to delivery | Cesarean delivery rate | Uterine tachystystole | EBL | Chorioamnioitis | Cord pH | 5-minute Apgar score | NICU admission
    • Statistical analysis
      • 80% power to detect a difference of 3 hours between the mean induction to delivery times would require a total of 188 patients (94 in each arm)

RESULTS:

  • 200 patients were randomized
    • 100 Foley and misoprostol | 100 misoprostol alone
  • Demographic and baseline measurements were similar between groups
  • Time to delivery was significantly shorter in the combined misoprostol-transcervical Foley group (P=.001)
    • Foley and misoprostol group: 15.0 (11.0-21.8) hours (median [interquartile range])
    • Misoprostol only: 19.0 (14.0-27.3) hours
  • This time difference remained significant after subanalysis by parity or after excluding cesarean deliveries
  • There was no difference between groups with respect to
    • Cesarean rate
    • Cesarean indication
    • EBL
    • Tachysystole
    • Chorioamnionitis
    • Neonatal outcomes

CONCLUSION:

  • Simultaneous Misoprostol and transcervical Foley bulb lead to shortened course of labor compared with misoprostol alone

Learn More – Primary Sources:

Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial.

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Related ObG Topics:

Foley Bulb Catheter for Induction Following PROM in Nulliparas
The FIAT-M study: Simultaneous or Sequential Foley and Oxytocin for Induction in Multiparous Women
Does Adding Mifepristone Prior to Misoprostol Improve Medical Management of Pregnancy Loss?

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