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.

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?