Comparison of efficacy of single-dose Oral Mifepristone with Transcervical Foley catheter for pre-induction cervical ripening in singleton term and late-term pregnancy - An Open-label Randomised Controlled Trial

Induction of labour is the most common obstetric procedure performed worldwide with an incidence of 25%.Success of labour induction depends on cervical “ripeness†or “favorabilityâ€.

Various pharmacological and mechanical methods are available for cervical ripening and induction of labor. Prostaglandin analogues like Dinoprostone(PGE2) and Misoprostol (PGE1) in various formulations are found to be more effective than Oxytocin,but are associated with the risk of uterine hyperstimulation, fetal distress and uterine rupture. Mechanical methods such asFoleycatheter and hygroscopic dilators are associated with decreased risk of uterine hyperstimulation but increased maternal and neonatal infectious morbidity.

Progesterone antagonist like Mifepristone has been extensively used for termination of pregnancy in 1st and 2nd trimester and term intrauterine fetal demise. It binds to progesterone receptor and blocks the action of progesterone at the cellular level thereby decreasing the myometrial quiescence state and increasing its sensitivity to uterotonic agents.

Several studies have shown that Mifepristone is a safe and effective way to ripen the cervix thereby inducing the labour process in term pregnancies with no adverse maternal or fetal events.There are no studies comparing the efficacy of Mifepristone with trans-cervical Foley catheter for pre-induction cervical ripening in term and late term pregnancy.

If this study results show better or comparable effect of Mifepristone as pre-induction ripening agent to Foley catheter, then it can be used in outpatient basis for cervical ripeningthereby decreasing hospital stay with less infectious morbidity.