Oral misoprostol alone versus oral misoprostol and Foley's catheter for induction of labor: A randomized controlled trial.

AIM: The aim of this study was to evaluate the efficacy of oral misoprostol and Foley's catheter versus oral misoprostol alone for induction of labor.

METHODS

This 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.

RESULTS

The 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).

CONCLUSION

The 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.