ABSTRACT... Objectives: To compare the efficacy of Metformin with insulin in gestational diabetes mellitus in terms of fetomaternal outcome. Study Deign: Randomized clinical trial study. Methodology: Total 500 pregnant females with GDM were included in the study through nonprobability, consecutive sampling. Patients were divided into 2 equal groups (A: B). Patients in group A were given tablet metformin 500 mg by oral route and group B was administrated regular injection Insulin by subcutaneous

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... route. Results: The mean age of females was 32.14±6.13 years. The mean gestational age was 31.07±3.8 weeks. There were 78 (15.6%) females who had 0 parity, 107 (21.4%) females had parity 1, 175 (35%) females had parity 2, 95 (19%) females had parity 3, 33 (6.6%) females had parity 4 and 12 (2.4%) females had parity 5.There were 54 (10.8%) cases had PTB, out of which 12 (4.8%) had PTB with metformin while 42 (16.8%) had PTB with insulin. There were 115 (23%) neonates required NICU admission, out of which 37 (14.8%) neonates with metforminand78 (31.2%) neonates with insulin. There were 87 (17%) neonates who had neonatal hypoglycemia, out of which 23 (9.2%) neonates with metformin and64 (25.6%) neonates with insulin. The difference was significant between both groups for all fetal outcomes (P<0.05). Conclusion: The metformin is more effective in preventing adverse fetal and maternal outcome as compared to insulin.