Pre-induction cervical ripening: A randomized controlled trial of vaginal dinoprostone gel vs double balloon catheter for induction of labour in nulliparous and multiparous women with unfavourable cervix

The main aim of this study is to compare the efficacy and patient satisfaction of two methods of labour induction in terms of singleton pregnancies of both nulliparous and multiparous women with an unfavourable cervix. The primary outcome was caesarean section rates between groups. The study used Randomised Controlled trial. The population of nulliparous and multiparous women with an unfavourable cervix requiring induction at term is (n=251). Two study arms were used: double-balloon catheter (n=116) and Dinoprostone gel (n=130). Five women, who were eligible, declined intervention. Three women from Dinoprostone gel group and six from the double-balloon catheter group were excluded from analysis due to protocol violations. There is no significant difference in delivery outcomes or rates of caesarean section between the interventions. Induction with Dinoprostone gel resulted in significantly more uterine hyperstimulation with no increase neonatal morbidity. Overall there was no difference in patient’s pain score or satisfaction between interventions regardless of parity. Labour induction with Dinoprostone gel or double-balloon catheter is equally efficacious and acceptable to women. We suggest that the method of induction should be dictated by clinicians' experience, facilities available and women’s preference. Further evaluation of cost and neonatal outcomes are important ongoing research areas.