SAFETY AND MATERNAL-FETAL OUTCOMES OF ISOSORBIDE MONONITRATE AND MISOPROSTOL COMBINATION VERSUS MISOPROSTOL ALONE FOR LABOR INDUCTION: A RANDOMIZED DOUBLE-BLIND STUDY

Abstract

Objective: The induction of labor is essential in managing pregnancies where early delivery benefits outweigh the risks. Misoprostol is a common agent for labor induction but has side effects like uterine hyperstimulation. Isosorbide mononitrate (ISMN), a nitric oxide donor, may enhance cervical ripening and reduce complications when used with misoprostol. This study evaluates the safety and maternal-fetal outcomes of ISMN combined with misoprostol versus misoprostol alone. Methods: A randomized, double-blind study was conducted at Dr. R. P. G. M. C. Kangra. Patients meeting the inclusion criteria were randomly assigned to receive either ISMN with misoprostol or misoprostol with a placebo. Primary outcomes measured were maternal complications (e. g., uterine hyperstimulation, headache, postpartum hemorrhage) and neonatal outcomes (e. g., birth weight, APGAR scores, NICU admission). Secondary outcomes included the need for oxytocin augmentation and the duration of labor stages. Results: The study included 100 patients divided into two groups of 50 each. The ISMN and misoprostol group had significantly fewer headaches and dizziness but showed no significant difference in uterine hyperstimulation or postpartum hemorrhage compared to the misoprostol alone group. The ISMN group required less oxytocin augmentation, and their total labor duration was shorter, though not significantly. Neonatal outcomes were similar across both groups. Conclusion: The combination of ISMN and misoprostol appears to be a safer and potentially more effective alternative to misoprostol alone for labor induction, with fewer maternal complications and similar neonatal outcomes. Further large-scale studies are recommended to confirm these findings and inform clinical practice.