83: Efficacy and safety of misoprostol vaginal insert compared with dinoprostone vaginal insert for labor induction


      To compare the efficacy and safety of a controlled-release 200 mcg misoprostol vaginal insert (MVI 200) to a 10 mg dinoprostone vaginal insert (DVI) for use in labor induction.

      Study Design

      This was a phase 3, double-blind, multicenter study conducted in pregnant women, aged 18 years or older and ≥ 36 weeks gestation, requiring cervical ripening prior to induction of labor (baseline modified Bishop score ≤ 4). Women were randomized to receive either MVI 200 or DVI. Vaginal inserts were removed at the onset of active labor, when adverse events required discontinuation of therapy, or at 24 hours post insertion. The primary efficacy outcome was the time from administration of the vaginal insert to vaginal delivery. The co-primary safety outcome was the rate of cesarean delivery.


      1360 women were randomized and data from 1358 women were included in the intent-to-treat analysis (MVI 200, n = 678; DVI, n = 680). No statistically significant differences were observed between treatment groups for baseline demographic or obstetric characteristics. Median time to vaginal delivery was significantly shorter for women treated with MVI 200 compared to DVI (21.5 hours [95% CI 20.0 - 23.4] vs 32.8 hours [95% CI 30.2 - 34.9], P < .001). Most women delivered vaginally (MVI 200 73.6% [499/678]; DVI 72.2 % [491/680]). The cesarean rates were similar between the MVI 200 (26.0% [176/678]) and DVI (27.1% [184/680]) treatment groups (p = 0.65; RR 0.96 [95% CI: 0.80 - 1.15]).


      MVI 200 reduced the time to vaginal delivery compared to treatment with DVI with similar rates of cesarean delivery.