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

B. H. Radhika, S. Soundara Raghavan


Objective: To compare the efficacy and safety of intravaginal misoprostol with intracervical dinoprostone for
preinduction cervical ripening. Material andMethods: It was a randomized controlled trial conducted at department
of obstetrics and gynecology, JIPMER, Puducherry. Three hundred women with Bishop score of less than 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 less than 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 less than 0.0001).Conclusion: Low dose misoprostol is as effective as dinoprostone in cervical ripening and
demonstrates similar fetal and maternal safety profile.


Misoprostol, Dinoprostone, Pre induction cervical ripening, Bishop score.

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DOI: https://doi.org/10.30750/ijpbr.1.3.9


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