Efficacy and safety of six hourly vaginal misoprostol versus intracervical dinoprostone: a randomized controlled trial.

OBJECTIVE: To compare the efficacy and safety of intravaginal misoprostol versus dinoprostone cervical gel for cervical ripening and labour induction.

METHODS: We carried out an experimental clinical trial in which we enrolled 130 cervical consecutive patients with cervical ripening, randomly assigned to one of the following two treatment groups: (1) intravaginal misoprostol and (2) intracervical dinoprostone gel. A total of 50 microm of misoprostol was placed in the posterior vaginal fornix every 6 h for a maximum period of 24 h and 0.5 mg of dinoprostone was administrated in the uterine cervix every 6 h, for a maximum period of 24 h. The primary outcome measure was the number (rate) of women who went to vaginally deliver within 24 h of the protocol initiation.

RESULTS: Among 130 patients evaluated, 65 were allocated to the misoprostol group and 65 to the dinoprostone group. The proportion of vaginal delivery within 24 h was significantly higher in the misoprostol group (75%) than in the dinoprostone group (53.8%) (RR = 1.40, 95% CI [1.07-1.45], P = 0.02). There was no significant difference between the mean time interval of delivery in the misoprostol group and the dinoprostone group (14.9 vs.15.8 h) (P = 0.51). The Bishop score was significantly higher in the misoprostol group, 6 h after the onset of the study (1.38; relative risk, 95% CI [1.02-1.85], P = 0.03). The Caesarean delivery rate for fetal distress was higher in the dinoprostone group (21 vs. 10.8%, P = 0.15). The tachysystole (Misoprostol 6.1% vs. dinoprostone 4.6%, relative risk 1.15, 95% CI [0.6-2.24]) and hyperstimulation syndrome rates (Misoprostol 7.6% vs. dinoprostone 4.6%, relative risk 1.26, 95% CI [0.72-2.24]) were slightly increased in the misoprostol group than in the dinoprostone group without reaching the level of statistical signification.

CONCLUSION: Misoprostol as used in this protocol is more effective than cervical dinoprostone gel application in the cervical ripening and labour induction. There is a tendency for an increase in the rate of tachysystole and hyperstimulation syndrome.