Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction

Phase IV, Multicenter, Open Label, Randomized Trial to Compare the Effectiveness and Safety of the Dinoprostone Vaginal Pessary vs. Oxytocin for Women Requiring Cervical Ripening Prior to Induction of Labor

This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.

Inclusion Criteria:

• Singleton pregnancy
• Gestational age ≥ 38 weeks
• Fetal cephalic presentation
• Bishop score < 6

Exclusion Criteria:

• No uterine scar (no previous delivery by caesarean section)
• No more than 3 previous vaginal births
• No condition that disallows use of prostaglandins for induction of labor
• Premature rupture of the membranes
• Oligohydramnios