RETRACTED: Oral misoprostol alone versus oral misoprostol and Foley's catheter for induction of labor: A randomized controlled trial (Retracted Article)

AimThe aim of this study was to evaluate the efficacy of oral misoprostol and Foley's catheter versus oral misoprostol alone for induction of labor. MethodsThis open-label randomized controlled trial included 335 women requiring induction of labor. A total of 166 women were randomly allocated to induction with oral misoprostol alone and 169 women were assigned for induction with Foley's balloon catheter and oral misoprostol using a computer-generated allocation sequence. The primary outcome was rate of failure to achieve vaginal delivery within 24 h of induction. ResultsThe proportion of women failing to achieve vaginal delivery within 24 h in the combination group was lower (11.8% vs 28.7%, P = 0.001). When the two groups were stratified according to parity, the difference remained statistically significant only for parous women. The median induction-to-delivery interval (13.0 h vs 19 h, P = 0.000) and the median number of doses of misoprostol used (2 vs 3, P = 0.000) were lower in the combination group. The number of women who delivered vaginally in the combination group was significantly higher (91% vs 79%, P = 0.001). More neonates born to women in the misoprostol group had Apgar scores<7 and were admitted to the neonatal intensive care unit (P = 0.016 and P = 0.007, respectively). ConclusionThe rate of failure to achieve vaginal delivery within 24 h was lower with Foley's balloon and oral misoprostol as compared to oral misoprostol alone.