Trans-cervical Foley catheter balloon versus vaginal prostaglandin E2 suppository for cervical ripening and induction of labor: a prospective randomized controlled trial

Objective To compare the effectiveness and safety of Foley catheter(FC)and vaginal prostaglandin E2 suppository(PGE2,Propess)for cervical ripening and labor induction in fullterm pregnant women with unfavorable cervix.Methods A prospective randomized controlled trial was conducted.Women with a term or post-term,live,singleton fetus in cephalic presentation,intact membranes,Bishop score＜6,not in labor,medically indicated for labor induction from June 2009 to December 2009 in Drum Tower Hospital of Nanjing University Medical School were randomly divided into two groups:FC group(n=64)and Propess group(n=62).In FC group,a 16-F Foley catheter was inserted into patient's cervical canal; once past the internal os,the balloon was inflated with 80 ml saline.Intravenous oxytocin was initiated after the balloon was spontaneously extruded from the cervix or after 24 hours.In Propess group,vaginal Propess was used.x2 or Fisher's exact test and t test were used to compare the outcomes,delivery mode and induction success rate between the two groups.Results There were no significant differences in gestational weeks,Bishop score,indication of induction,improvement of Bishop score,success rate of induction,rate of vaginal delivery,total duration of labor and volume of postpartum hemorrhage between the two groups(P ＞ 0.05,respectively).Propess group had a higher rate of vaginal birth within 24 hours[56.5％(35/62)vs 28.1％(18/64),t=10.37,P＜0.05],a higher risk for excessively frequent and hard uterine contraction[17.7％(11/62)vs 0.0％(0/64),P＜0.05]and lower incidence of oxytocin induction/augmentation during labor[21.0％(13/62)vs 87.5％(56/64),x2 =56.27,P＜0.05]than those of FC group.There were no differences in neonatal Apgar score,meconium staining and neonatal birth weight between the two groups.Puerperal infection occured in neither group.Conclusions Under strict control of indication and aseptic manipulation,Foley catheter was as effective and safe as Propess for cervical ripening with lower risk of excessive uterine activity.It is suggested that Foley catheter could be used for cervical ripening,especially in patients with economic difficulty. Key words: Cervical ripening;  Labor;  induced;  Dinoprostone;  Randomized controlled trial