Randomized clinical trial between hourly titrated oral misoprostol and vaginal dinoprostone for induction of labor.

Objective The objective of the study was to compare the efficacy and safety of hourly titrated oral misoprostol with vaginal dinoprostone insert. Study Design Subjects were randomized into hourly titrated oral misoprostol or dinoprostone 10 mg vaginal insert. Misoprostol was given as 20 μg hourly for 2 doses. In the absence of regular uterine contractions, the dose was increased to 30 μg hourly for 3 doses and then 40 μg for 1 dose, 50 μg for 1 dose, and 60 μg hourly for 4 doses. Before the 40 and 50 μg doses, 1 more hour of observation was given. The primary outcome variable was vaginal delivery within 24 hours. Safety assessments included the incidence of maternal morbidity and adverse neonatal outcomes. Results A total of 160 women was enrolled in the study. The groups were similar for demographic and clinical factors. Vaginal delivery was achieved within 24 hours in 100 women (62.5%): 44 in the dinoprostone group (55.0%) and 56 in the misoprostol group (70.0%) ( P  = .05). The proportion of women who achieved vaginal delivery within 24 hours was significantly greater for nulliparous women in the misoprostol group (24 of 51, 58.5%) compared with the dinoprostone group (12 of 36, 33.3%; P  = .0270). Significantly more women with baseline Bishop score of 3 or less in the misoprostol group had successful induction (43 of 59, 72.9%) compared with the dinoprostone group (27 of 60, 45.0%; P  = .002). Frequencies of maternal adverse events were similar between groups. Conclusion Hourly titrated oral misoprostol can provide an efficacious and safe substitute for the expensive dinoprostone vaginal insert.