A prospective randomized comparative study of intra-cervical Foley\s catheter insertion versus PGE2 gel for pre-induction cervical ripening

Background: The success of induced labor depends on the degree of ripening of cervix. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, this study has been conducted to prove the efficacy and safety of extra amniotic Foley catheter balloon and to compare it with intracervical prostaglandin E2 (PGE2) gel. Aims and objectives: The success of induction of labor depends on the cervical status at the time of induction. Objective for effective cervical ripening both Foley's catheter and PGE 2 gel are used. The aim of this study was to compare the efficacy of intra cervical Foley's catheter and intra cervical PGE 2 gel in cervical ripening for the successful induction of labor. Methods: A randomized, prospective study was conducted in the Dept of OBGY, Krishna institute of medical sciences, deemed university Karad, from January 2011-December 2012. 400 patients at term with a Bishop's score <3 with various indications for induction were randomly allocated to receive (200 pts) intra-cervical Foley's catheter or PGE 2 gel (200 pts). After 6 h post induction, Bishop's score was noted labor was augmented if required. Statistical analysis was done using Chi square test and t test. Results: The groups were comparable with respect to maternal age, gestation age, indication of induction and initial Bishop's score. Both the groups showed significant change in the Bishop's score, 5.54 ± 1.89 and 5.44 ± 1.82 for Foley's catheter and PGE 2 gel, respectively, P<0.001; However there was no significant difference between the two groups. There was no significant difference in the side effects and caesarean section rate in both groups. The induction to delivery interval was 15.34 ± 5.24 h in Group A and 14.2 ± 5.24 h in Group B ( p =0.291). Apgar scores, birth weights and NICU admissions showed no difference between the two groups. Conclusions: This study shows that both Foley's catheter and PGE 2 gel are equally effective in pre induction cervical ripening.