Publication:

Comparison of the efficacy of extra amniotic Foley catheter, intravaginal prostaglandin E1 tablet and intracervical prostaglandin E2 gel for pre induction cervical ripening: a randomized comparative study

Background To compare the efficacy, efficiency and safety of extra amniotic Foley catheter with intracervical PGE2 gel and intravaginal misoprostol tablet for pre induction cervical ripening. Design of the study was to prospective randomized comparative study. Settings includes, this study was conducted in Mahatma Gandhi Medical College and Research Institute, Puducherry during November 2009 to May 2011.

Methods Participants for pre induction cervical ripening were randomized to receive either extra amniotic Foley catheter, intravaginal misoprostol tablet 25µg every four hours or intracervical PGE2 gel 0.5mg every six hours. The post ripening Bishop Score at 12 hours and 24 hours were assessed. The outcome measured was the time taken by the participants to achieve Bishop Score >5. The other outcomes included induction ripening interval, induction delivery interval, mode of delivery, requirement of additional agents, maternal and fetal complications.

Results The post ripening Bishop Score was significantly higher in PGE2 gel group with statistical significance. The induction ripening and the induction delivery interval was significantly shorter in misoprostol tablet group with a ‘p’ value <0.001. The incidence of NICU admission and other complications like meconium stained liquor, respiratory distress and maternal fever were more associated with misoprostol tablet group.

Conclusions PGE2 gel is an efficient agent for pre induction cervical ripening when compared to Foley catheter and misoprostol tablet though it is expensive, unstable and requires refrigeration. Tablet misoprostol significantly reduces the ripening duration, ripening delivery interval and the total duration to delivery. Misoprostol tablet is inexpensive, stable at room temperature and easy to administer. It also reduces the need for oxytocin augmentation. However the safety of misoprostol is still a concern due to increased maternal and neonatal complications. Foley catheter alone is not a good cervical ripening agent.