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Comparison of efficacy and safety of sublingual misoprostol with intracervical dinoprostone gel for cervical ripening in prelabour rupture of membranes after 34 weeks of gestation.
PURPOSE: To compare the efficacy and safety of sublingual misoprostol with intracervical dinoprostone gel for cervical ripening in prelabour rupture of membrane after 34 weeks of gestation.
METHODS: One eighty-eight women having >34 weeks of gestation with PROM, singleton viable fetus and no prior caesarean section were randomized to sublingual misoprostol (50 μg every 4 h and maximum of 3 doses) and intracervical dinoprostone (0.5 mg every 2 h and maximum of 2 doses). Oxytocin augmentation was commenced in those with a satisfactory Bishop score, inadequate contractions and who did not go into spontaneous active labour. Primary outcome measures were induction-delivery interval and the number of women that went into spontaneous labour without oxytocin augmentation.
RESULTS: There was a significant reduction in induction to delivery interval in sublingual misoprostol group compared to intracervical dinoprostone (8.3 ± 3.6 h vs 12.2 ± 6.6 h; p = 0.000). There was a significant reduction in duration of rupture of membrane to delivery interval (p = 0.015), 1st stage of labour (p = 0.000) in sublingual misoprostol group as compared to the intravaginal dinoprostone group. There was no difference observed in spontaneous vaginal delivery between the groups (0.919). Oxytocin requirement was significantly higher in the dinoprostone group p = 0.006). There were more maternal adverse effects of sublingual misoprostol (p = 0.026). However, maternal and neonatal safety profiles were comparable.
CONCLUSIONS: Sublingual misoprostol and intracervical dinoprostone at the dose studied are equally efficacious in achieving spontaneous vaginal delivery, reduction in induction-delivery interval and in reducing the need for oxytocin, in women after 34 weeks gestation with rupture of membranes.
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