A Randomised Controlled Trial Comparing Intravaginal Misoprostol and Intracervical Dinoprostone in Pre Induction Cervical Ripening.

ABSTRACT

Objective: To compare the efficacy and safety of intravaginal misoprostol with intracervical dinoprostone for preinduction cervical ripening. Material &Methods: It was a randomized controlled trial conducted at department of obstetrics and gynecology, JIPMER, Puducherry. Three hundred women with Bishop score of <6, were assigned randomly to receive either intravaginal misoprostol 25 μg every four hours for four doses, and intracervical dinoprostone gel 0.5 mg every eight hours for two doses. (one hundred women in each group). Oxytocin was initiated as per standardized protocol, if the cervix was favourable. If the cervical ripening was unsuccessful (Bishop score < 6) after the maximum doses of drugs in both the groups, then further treatment was individualized. Efficacy and cost of the drugs were compared in both groups. Results: Primary outcome measure was change in Bishop score. Mean Bishop score change at the end of 16 hours was significantly higher in the misoprostol group, (2.57±0.59) compared to dinoprostone group (2.17±0.10, p=0.016). This finding was inspite of the fact that the dinoprostone group had higher Bishop score prior to the ripening.(3.55±0.56 vs 3.28±0.77, p=0.006). Secondary outcome measures such as mean intervention-delivery interval, oxytocin requirement, mode of delivery, maternal and neonatal outcomes were similar in both the groups. Overall mean cost of ripening agent per patient was significantly less in the misoprostol group, (22.56±93.16 rupees) compared to dinoprostone group (493.89±173.99 rupees, p<0.0001).Conclusion: Low dose misoprostol is as effective as dinoprostone in cervical ripening and demonstrates similar fetal and maternal safety profile.