Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set.

AIMS: With the rising number of outcomes being reported following gestational diabetes (GDM), the outcomes in existing studies vary widely making it challenging to compare and contrast the effectiveness of different interventions for GDM. The purpose of this study was to develop a core outcome and measurement set (COS) for GDM treatment trials. MATERIALS & METHODS: A Delphi study with structured consultation with stakeholders and discussion within a specialist Gestational Metabolic Group (GEM) were combined with a comprehensive systematic search across different databases (PubMed, Cochrane Library, and Embase). Several Delphi rounds over 2 years were conducted culminating in this report. RESULTS: The process resulted in a targeted set of outcomes constituting a "GEM treatment set" aligned with expert opinion. The final COS also included a measurement set for the 11 important clinical outcomes from three major domains: maternal metabolic, fetal, and pregnancy related. CONCLUSIONS: Based on the results of this study, it is recommended that future clinical trials on GDM report outcomes uniformly keeping to the recommended COS outcomes.

Metformin is comparable to insulin for pharmacotherapy in gestational diabetes mellitus: A network meta-analysis evaluating 6046 women.

CONTEXT: The comparative efficacy of gestational diabetes (GDM) treatments lack conclusive evidence for choice of first-line treatment. OBJECTIVES: The aim of this study was to compare the efficacy of metformin and glibenclamide to insulin using a core outcome set (COS) to unify outcomes across trials investigating the treatment of gestational diabetes mellitus. STUDY DESIGN: A network meta-analysis (NMA) was conducted. DATA-SOURCE: PubMed, Embase, and Cochrane Controlled Register of Trials were searched from inception to January 2020. STUDY SELECTION: RCTs that enrolled pregnant women who were diagnosed with GDM and that compared the efficacy of different pharmacological interventions for the treatment of GDM were included. META-ANALYSIS: A generalized pairwise modelling framework was employed. RESULTS: A total of 38 RCTs with 6046 participants were included in the network meta-analysis. Compared to insulin, the estimated effect of metformin indicated improvements for weight gain (WMD -2·39 kg; 95% CI -3·31 to -1·46), maternal hypoglycemia (OR 0.34; 95% CI 0.12 to 0·97) and LGA (OR 0.61; 95% CI 0.38 to 0·98). There were also improvements in estimated effects for neonatal hypoglycemia (OR 0.48; 95% CI 0.19 to 1·25), pregnancy induced hypertension (OR 0.63; 95% CI 0.37 to 1·06), and preeclampsia (OR 0.74; 95% CI 0.538 to 1·04), though with limited evidence against our model hypothesis of equivalence with insulin for these outcomes. CONCLUSION: Metformin is, at least, comparable to insulin for the treatment of GDM. Glibenclamide appears less favorable, in comparison to insulin, than metformin.

Physical activity in pregnancy prevents gestational diabetes: A meta-analysis.

AIMS: The effectiveness of physical activity (PA) programs for prevention of gestational diabetes (GDM) lacks conclusive evidence. The aim of this study was to generate clear evidence regarding the effectiveness of physical activity programs in GDM prevention to guide clinical practice. METHODS: PubMed/Medline, ISI Web of Science, Scopus, and EMBASE were searched to identify the randomized trials (RCTs) published until June 2019. Randomised controlled trials enrolling women at high risk before the 20th week of gestation comparing the effect of PA interventions with usual care for prevention of GDM were retrieved. Data obtained were synthesised using a bias-adjusted model of meta-analysis. RESULTS: A total of 1467 adult women in 11 eligible trials were included. The risk of GDM was significantly lower with PA, but only when it was delivered in the healthcare facility (RR 0.53; 95% CI 0.38-0.74). The number needed to treat with PA in pregnancy (compared to usual care) to prevent one GDM event was 18 (95% CI 14 - 29). The overall effect of PA interventions regardless of location of the intervention was RR 0.69 (95% CI 0.51 - 0.94). CONCLUSIONS: This study provides evidence that in-facility physical activity programs started before the 20th week of gestation can significantly decrease the incidence of GDM among women at high risk.