The Effect of Myo-Inositol Supplementation During Pregnancy on Fetal and Maternal Outcomes: Results of the Myo-Inositol for the Prevention of Gestational Diabetes Mellitus (MiGDM) Randomized Double-Blind, Placebo-Controlled Pilot Trial
Abstract
Gestational diabetes mellitus (GDM) is a common pregnancy complication with significant maternal and neonatal risks, and its prevalence is particularly high in Qatar. Myo-inositol has been proposed as an insulin-sensitizing supplement that may reduce the incidence of GDM, but evidence is limited in this population. This study aims to evaluate the effect of antenatal dietary myo-inositol supplementation on the incidence of GDM among pregnant women in Qatar and to assess the impact on fetal and neonatal outcomes. Sidra Medicine, Qatar, conducted this prospective, randomized, double-blind, placebo-controlled pilot trial (2022-2023). The trial was registered with International Standard Randomised Controlled Trial Number (ISRCTN; protocol number ISRCTN16448440) and approved by the Institutional Review Board of Sidra Medicine (IRB Number: 1538656). Only 67 pregnant women were recruited, and 43 of them finished the trial till birth, despite the study's initial power to enrol 640 pregnant women (320 each group). This was due to funding-related early discontinuation. Eligible women were ≤16 weeks of gestation, planned to deliver at the study center, and had no pre-gestational diabetes. Participants were randomized to receive either myo-inositol supplementation (2 g twice daily) or a placebo until delivery. Data collection included maternal demographics, anthropometric measurements, and pregnancy and neonatal outcomes. The primary outcome was the incidence of GDM diagnosed by oral…
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: 640 participants or records.
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