Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

Summary

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

Timeline

Start

2025-06-01

Primary completion

2026-06-30

Completion

2026-06-30

Publications

• Background Peterson C, Grosse SD, Li R, Sharma AJ, Razzaghi H, Herman WH, Gilboa SM. Preventable health and cost burden of adverse birth outcomes associated with pregestational diabetes in the United States. Am J Obstet Gynecol. 2015 Jan;212(1):74.e1-9. doi: 10.1016/j.ajog.2014.09.009. Epub 2014 Oct 28.
• Background Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes Care. 2008 May;31(5):899-904. doi: 10.2337/dc07-2345. Epub 2008 Jan 25.
• Background Temple R, Murphy H. Type 2 diabetes in pregnancy - An increasing problem. Best Pract Res Clin Endocrinol Metab. 2010 Aug;24(4):591-603. doi: 10.1016/j.beem.2010.05.011.
• Background Lee AM, Fermin CR, Filipp SL, Gurka MJ, DeBoer MD. Examining trends in prediabetes and its relationship with the metabolic syndrome in US adolescents, 1999-2014. Acta Diabetol. 2017 Apr;54(4):373-381. doi: 10.1007/s00592-016-0958-6. Epub 2017 Jan 9.
• Background Chen L, Pocobelli G, Yu O, Shortreed SM, Osmundson SS, Fuller S, Wartko PD, Mcculloch D, Warwick S, Newton KM, Dublin S. Early Pregnancy Hemoglobin A1C and Pregnancy Outcomes: A Population-Based Study. Am J Perinatol. 2019 Aug;36(10):1045-1053. doi: 10.1055/s-0038-1675619. Epub 2018 Nov 30.
• Background Professional Practice Committee for the Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016 Jan;39 Suppl 1:S107-8. doi: 10.2337/dc16-S018. No abstract available.

Drugs

Indications