Abdulrahim A Rouzi1, Sharifa Alsibiani2, Nisma Mansouri2, Nawal Alsinani2, Khalid Darhouse2. 1. Department of Obstetrics and Gynecology, King Abdulaziz University, Jeddah, Saudi Arabia. Electronic address: aarouzi@gmail.com. 2. Department of Obstetrics and Gynecology, King Abdulaziz University, Jeddah, Saudi Arabia.
Abstract
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.
RCT Entities:
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.
Authors: P Tsikouras; Z Koukouli; B Manav; M Soilemetzidis; A Liberis; R Csorba; G Trypsianis; G Galazios Journal: Geburtshilfe Frauenheilkd Date: 2016-07 Impact factor: 2.915
Authors: Robbie S Kerr; Nimisha Kumar; Myfanwy J Williams; Anna Cuthbert; Nasreen Aflaifel; David M Haas; Andrew D Weeks Journal: Cochrane Database Syst Rev Date: 2021-06-22