Long-Term Study of Metformin Added to Diet and Lifestyle in Pregnant Women with Gestational Diabetes to Improve Outcomes for Mother and Child

What this Trial Is About

Gestational diabetes mellitus GDM is a growing concern worldwide, affecting 5-10% of pregnancies and leading to risks during pregnancy, delivery, and long-term health problems such as type 2 diabetes and obesity for both mother and child. This research aims to evaluate whether metformin, given early from the time of GDM diagnosis alongside diet and lifestyle changes, improves important pregnancy outcomes over many years. The study is a randomized controlled trial called the POEM study, designed to fill the gap in research on early metformin use in GDM treatment. The trial involves three phases Phase A lasts from the start of the study until six weeks after delivery, comparing two groupsone receiving diet, lifestyle advice, and metformin, and the other receiving diet and lifestyle advice alone, with insulin rescue if needed. Phase B continues from six weeks to one year after delivery, focusing on the mothers ongoing treatment with or without metformin. Phase C is an observational follow-up from one to 20 years after delivery, monitoring mother and child without study medication. Metformin dosing ranges from 850 mg once to three times daily, adjusted based on tolerance. Participants will have regular assessments including blood glucose tests, pregnancy outcome measures summarized by a new GDM Outcome Score, and long-term monitoring of type 2 diabetes and obesity in mother and child. Researchers will collect data through clinical visits, laboratory tests, and questionnaires over up to 20 years. Safety and compliance will be monitored throughout, and the study aims to provide meaningful insights into managing GDM and its effects over time.

Pregnancy Outcomes: Effects of Metformin Study (POEM Study)