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Changing Paradigms: Neonatal Outcomes after Oral Metformin versus Insulin in the Control of Gestational Diabetes Mellitus (Randomized controlled trial)

Abd El Tawwab AE, Mahmoud MS, El-Kady HA, Elashiry AA, Elsayed HG, Seifelnasr MF

La Clinica terapeutica, 2025

200 participants

Abstract

BACKGROUND: Although metformin can cross the placenta, its utility in treating gestational diabetes mellitus (GDM) is still debatable.

AIM: The purpose of this study was to assess how metformin and insulin affect the outcomes for mothers and newborns in GDM patients.

PATIENTS AND METHODS: 200 individuals with gestational diabetes who were enrolled in the outpatient clinic at Fayoum University Hospitals (obstetrics and gynecology clinic and family medicine clinic) between March 2024 and August 2024 were the subjects of this randomized controlled research. Patients who satisfied the inclusion and exclusion criteria were randomized to receive either insulin or metformin therapy groups. Blood glucose levels were measured both at enrollment and follow-up appointments. Both maternal and fetal outcomes were the results.

RESULTS: Fasting blood sugar, glycated hemoglobin and 2 hours' postprandial blood sugar did not show significant differences (P >0.05) between the two groups. Additionally, Metformin was beneficial in reducing neonatal birth weight. Also, neonates in the metformin-treated group suffered fewer rates of neonatal hypoglycemia and NICU admission. Maternal hypoglycemia was lower in the metformin group, and patient compliance was higher in the same group (P <0.05).

CONCLUSIONS: We may draw the following conclusions from the current study's results that oral metformin was just as effective in managing and controlling gestational diabetes mellitus as insulin injection. 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: 200 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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