AIM: Prospective clinical trials were conducted to assess the safety and efficacy of 6-hourly vaginal misoprostol versus intracervical dinoprostone for induction of labor. METHODS: A total of 120 pregnant women requiring induction of labor were recruited. Cases were randomized to receive either 50 microg vaginal misoprostol 6 hourly (group 1, n = 60) or 0.5 mg intracervical dinoprostone 6 hourly (group II, n = 60). Outcome measures, such as change in Bishop's score, need of oxytocin, induction delivery interval; complications like tachysystoly, hyperstimulation, abnormal fetal heart rate, and meconium passage were compared between two groups. Statistical analysis was performed by Wilcoxan's Rank sum and Student's t-test. RESULTS: Bishop score rise, after 6 h of initiation of therapy was significantly higher in the misoprostol group than dinoprostone, 2.98 +/- 2.57 versus 2.05 +/- 1.83 (P = 0.04). The need of oxytocin augmentation was reduced in misoprostol versus dinoprostone group, 16.6% versus 78.3% (P = <0.001). Induction delivery interval was shorter in misoprostol; 12.8 +/- 6.4 h versus 18.53 +/- 8.5 h in dinoprostone group (P = <0.01). One case (1.6%) in misoprostol group, but none in dinoprostone had tachystole (P = 1.00). Abnormal heart rate pattern was found more in misoprostol than dinoprostone 16.6% versus 4.9% (P = 0.14) and so was the incidence of cesarean section, 26.6 versus 15%, respectively (P = 0.47). Meconium passage was the same in both groups, 10% in each group. CONCLUSION:Vaginal misoprostol 50 microg 6-hourly is safe and effective for induction of labor with lesser need of oxytocin augmentation and shorter induction delivery interval.
RCT Entities:
AIM: Prospective clinical trials were conducted to assess the safety and efficacy of 6-hourly vaginal misoprostol versus intracervical dinoprostone for induction of labor. METHODS: A total of 120 pregnant women requiring induction of labor were recruited. Cases were randomized to receive either 50 microg vaginal misoprostol 6 hourly (group 1, n = 60) or 0.5 mg intracervical dinoprostone 6 hourly (group II, n = 60). Outcome measures, such as change in Bishop's score, need of oxytocin, induction delivery interval; complications like tachysystoly, hyperstimulation, abnormal fetal heart rate, and meconium passage were compared between two groups. Statistical analysis was performed by Wilcoxan's Rank sum and Student's t-test. RESULTS: Bishop score rise, after 6 h of initiation of therapy was significantly higher in the misoprostol group than dinoprostone, 2.98 +/- 2.57 versus 2.05 +/- 1.83 (P = 0.04). The need of oxytocin augmentation was reduced in misoprostol versus dinoprostone group, 16.6% versus 78.3% (P = <0.001). Induction delivery interval was shorter in misoprostol; 12.8 +/- 6.4 h versus 18.53 +/- 8.5 h in dinoprostone group (P = <0.01). One case (1.6%) in misoprostol group, but none in dinoprostone had tachystole (P = 1.00). Abnormal heart rate pattern was found more in misoprostol than dinoprostone 16.6% versus 4.9% (P = 0.14) and so was the incidence of cesarean section, 26.6 versus 15%, respectively (P = 0.47). Meconium passage was the same in both groups, 10% in each group. CONCLUSION: Vaginal misoprostol 50 microg 6-hourly is safe and effective for induction of labor with lesser need of oxytocin augmentation and shorter induction delivery interval.