Comparing two Prepidil gel regimens for cervical ripening before induction of labor at term: a randomized trial

To compare efficacy and safety of two regimens of intracervical dinoprostone (Prepidil) in cervical ripening before labor induction at term. This was a prospective randomized clinical study including 148 patients with single pregnancy, viable fetus at gestational age greater than 36 weeks gestation and a Bishop score less than five, who required induction of labor. Patients were randomised to receive either repeated doses of dinoprostone gel 0.5mg (Prepidil) every 6 hours (group I) or every 12 hours (group II) for maximum three times before inducing labor with Oxytocin. The main outcome was the rate of caesarean sections. The two groups were similar in patient characteristics, indication for labor induction and preinduction Bishop scores. The caesarean rate was lower in group I (20.3%) than in group II (23%); though the difference did not reach statistical difference: p=0.69. Delivery rate in the first 24 hours was significantly higher in group I (62.2%) than in group II (40.5%); p=0.009. Prepidil secondary effects were experienced in 8.1% of patients in group I versus 1.4% in group II; p=0.11. Median umbilical artery pH at birth was 7.232+/-0.47 in group I and 7.294+/-0.58 in group II; p=0.30. Maternofetal infections rate was lower in group I (1.4%) than in group II (2.7%) without significant difference (p=0.56). Repeated intracervical doses of Prepidil every 6 hours, in cervical ripening before labor induction at term, enables higher delivery rate in the first 24 hours without inducing excess of caesarean sections or maternofetal morbidity when compared to its administration every 12 hours.