Simultaneous use of high-volume Foley catheter (60ml) and misoprostol for labor induction in nulliparous women: Arandomized controlled trial.

Abstract

To examine the simultaneous effect of high-volume Foley catheter (HVFC) (60ml) and vaginal misoprostol on labor induction in nulliparous women. A randomized, double-blind, controlled trial was conducted among nulliparous post-date (>40weeks) pregnant women between June and December 2019. At enrollment 100 women were randomized into each group (either HVFC and vaginal misoprostol or low-volume Foley catheter [LVFC] [30ml] and vaginal misoprostol), for labor induction. Demographic and clinical data were collected at enrollment and delivery. Women in the HVFC group had statistically significantly shorter induction to delivery interval (median 860min, interquartile range [IQR] 840-940min vs. 1160min, IQR 1080-1320min, P<0.001) and duration of labor (median 615min, IQR 600-680min vs. 750, IQR 692.5-800min, P<0.001). Mode of vaginal delivery (n=94 vs. n=78, P=0.002), number of doses of misoprostol required (median 2, IQR 1-2 vs. 2, IQR 1-3), and need of oxytocin augmentation (n=22 vs. n=39, P=0.014 and P<0.001), was significantly better in the HVFC group. However, there was no significant difference with respect to other maternal or neonatal outcomes. Simultaneous use of HVFC and vaginal misoprostol for labor induction significantly shortens the induction to delivery interval and duration of labor in nulliparous women. Clinical Trial Registry of India CTRI/2019/05/019394 (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31554&EncHid=&userName=Foley%20catheter).