Abstract

This study compares the safety and efficacy of two dinoprostone formulations – a pessary and a gel. A retrospective randomised observational study was conducted to compare Dinoprostone controlled release pessary and Dinoprostone gel for induction of labor at term in women with unfavourable cervix at Apollo Hospitals BGS, Mysuru during August 2018 – May 2020. Among study participants 50 expectant mothers received Dinoprostone pessary while 50 women received Dinoprostone gel for induction of labour. Both groups were compared and the outcomes were analysed. The primary outcomes of the study were induction to delivery interval, successful vaginal delivery, need for operative vaginal delivery and need for caesarean section. Secondary outcomes were observed for neonatal morbidity and uterine hyperstimulation. There was a significant (p=<0.001) improvement in Bishop scores after induction in both groups. When only the post-induction scores for the two formulations were compared, the pessary helped to improve the bishops score (or helps in cervical ripening) better than the gel formulation and therefore can help to improve the chances of vaginal delivery(because there is a significant change in post induction bishop score in pessary group). The mean interval from induction to delivery for the pessary group was 11.03±4.648 hours and for the gel it was 21.18±9.127 hours with a significant p value <0.005The pessary showed a significant improvement in the post-induction Bishop score and a shorter induction to delivery time compared to the gel. Differences in the mode of delivery were not significant. Fortunately, no serious side effects to the mother or fetus were observed with both products. Both formulations of dinoprostone are safe for induction of labor at term. However, pessary achieves comparitively a higher rate of spontaneous vaginal delivery with a shorter labor induction time. Ease of administration, single application and thus decreased chance of infections are its additional benefits.

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