MOMPOD Trial: Assessing Metformin in Pregnancy and Insulin for Diabetes Management
Introduction: Managing Diabetes in Pregnancy
The management of diabetes during pregnancy remains a significant medical concern due to potential adverse outcomes for both mothers and their infants.
The MOMPOD (Metformin in Obese Moms to Prevent Macrosomia and Promote Normal Insulin Dynamics) trial sought to investigate whether supplementing insulin treatment with Metformin in Pregnancy individuals with preexisting type 2 diabetes or diabetes identified in the early stages of pregnancy could mitigate the risk of adverse neonatal outcomes.
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Background of the MOMPOD Trial
The study, conducted between April 2019 and November 2021 across 17 centers in the United States, enrolled 794 pregnant adults aged 18 to 45 years with preexisting type 2 diabetes or diabetes diagnosed before 23 weeks’ gestation.
Each participant received insulin treatment and was randomly assigned to either add metformin or a placebo to their regimen. The trial concluded follow-up in May 2022.
Study Design and Participants
The primary aim was to assess the impact on a composite adverse neonatal outcome, encompassing factors such as perinatal death, preterm birth, being either large or small for gestational age, and hyperbilirubinemia necessitating phototherapy.
Maternal hypoglycemia and newborn fat mass were secondary outcomes. Subgroup analyses were conducted based on maternal body mass index (BMI) and the distinction between preexisting diabetes and diabetes diagnosed in early pregnancy.
Intervention and Outcome Measures
The findings, however, revealed that while the addition of Metformin in Pregnancy to insulin did not significantly reduce the composite adverse neonatal outcome compared to the placebo group (71% vs. 74%), there was a notable decrease in the occurrence of infants being large for gestational age in the metformin-treated group.
The study was halted at 75% accrual due to the futility of detecting a significant difference in the primary outcome.
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Trial Findings: Impact on Neonatal Outcomes
Subsequent analysis of the individual components within the composite adverse neonatal outcome unveiled that infants exposed to metformin had reduced odds of being classified as large for gestational age compared to those in the placebo group.
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Secondary Outcomes and Subgroup Analyses
Despite the overall outcome indicating no substantial impact on the composite adverse neonatal outcome, the reduction in the likelihood of infants being large for gestational age after the inclusion of Metformin in Pregnancy in the treatment regimen suggests a potential avenue for further investigation.
This observed effect prompts a need for deeper exploration to better comprehend the mechanisms underlying metformin’s influence on fetal growth and to determine its clinical implications in using Metformin in Pregnancy
Conclusion: Insights from the MOMPOD Trial
In conclusion, the MOMPOD trial demonstrated that utilizing Metformin in Pregnancy alongside insulin for the management of preexisting type 2 diabetes or gestational diabetes identified in early pregnancy did not lead to a significant reduction in a composite adverse neonatal outcome.
However, the noteworthy reduction in the likelihood of infants being large for gestational age warrants further comprehensive investigation and analysis to discern the full scope of metformin’s impact in this context.