Effectiveness and acceptability of myoinositol in prevention of gestational diabetes mellitus A protocol for systematic review and meta-analysis

Background: The existing meta-analyses and randomized studies on myoinositol are of poor quality, with small sample sizes, and involve a homogeneous population. The general applicability of these findings to the National Health Service is unclear. We thus conduct this new high-quality systematic review and meta-analysis to assess the efficacy and safety of myoinositol in pregnant woman. Methods: The study protocol will be developed and executed in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. All of the following inclusion criteria in the PICOS order will be met by the studies included in our meta-analysis: 1. population: pregnant woman without gestational diabetes mellitus (GDM); 2. intervention: group with myoinositol; 3. comparison intervention: group without myoinositol; 4. outcome measures: at least one of the following outcome measures should to be reported: rate of GDM, offspring birthweight, fasting glucose, oral glucose tolerance test, and the side effects associated with the myoinositol; and 5. study design: English randomized trials. The following electronic databases will be searched: PubMed, Scopus, EMBASE, and Cochrane Library databases. The Cochrane risk of bias tool will be used to evaluate the risk of bias of the included randomized trials by 2 independent reviewers. Results: We will perform a meta-analysis using standard techniques for the outcomes. Conclusions: It was hypothesized that myoinositol supplementation could increase the action of endogenous insulin and prevent GDM and its complications.