Effectiveness of Metformin Prolonged-Release Formulation on Achievement of Optimal Glycemic Control in Gestational Diabetes Mellitus: Protocol for a Pilot, Randomized, Double-Blind, Clinical Trial
Abstract
Background: Gestational diabetes mellitus (GDM) is one of the most common complications in pregnancy. Optimal glycemic control is key to reducing the risk of adverse pregnancy outcomes. If glycemic control is inadequate, additional medications are needed. A large body of evidence has shown that metformin is an effective medication for GDM. Compared to the immediate-release formulation, the prolonged-release (PR) formulation of metformin offers some advantages with a single daily dose and has less frequent side effects, leading to better compliance. To date, no study has specifically reported the effectiveness of metformin PR in the treatment of GDM or the time required to achieve glycemic control after treatment. The results will help clinicians plan a better choice of treatment and follow-up for women with GDM and inadequate glycemic control.
Objective: This study aims to evaluate the effectiveness of metformin PR in the treatment of GDM in terms of achieving glycemic control within 6 weeks, time to achieve glycemic control, and associated factors.
Methods: A randomized, double-blind, placebo-controlled clinical trial will be conducted among 80 pregnant women diagnosed with GDM who had inadequate glycemic control at a university hospital in Thailand. The women will be randomized into 2 equal groups, receiving either metformin PR or a placebo in addition to nutritional therapy and behavioral modification. Dosage adjustment will be made every 2 weeks. If the glycemic target…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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