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:
population: pregnant woman without gestational diabetes mellitus (GDM);
intervention: group with myoinositol;
comparison intervention: group without myoinositol;
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
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.
Trial registration:: 10.17605/OSF.IO/9W8DV.