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Master Thesis

Sécurité d’utilisation de la metformine au cours de la grossesse : étude pharmaco-épidémiologique à partir du système national des données de santé

Abstract : This study aims to evaluate the risk for birth defects associated with first-trimester exposure to metformin. A cohort of women with a pregnancy starting in 2016 was created using data from the French nationwide healthcare data system. The risk of birth defects among pregnant women exposed to metformin during the first trimester for pregestational diabetes was compared to the risk among: 1) women with pregestational diabetes treated with insulin alone during the first trimester, and 2) non-diabetic women not exposed to any antidiabetic drug during pregnancy. The risk of birth defects was 6.7% (27/405) in pregnancies exposed to metformin, 10.6% (145/1376) in those exposed to insulin and 6.2% (29 243/473 021) in the group of women with no diabetes. Compared to the diabetic reference group treated exclusively with insulin, the adjusted relative risk (aRR) of birth defects overall and cardiac birth defects associated with metformin exposure were 0.64 (95%CI, 0.42-0.96) and 0.43 (95%CI, 0.20- 0.98) respectively. Relative to the non-diabetic reference group, the aRR of birth defects overall and cardiac birth defects were 1.07 (95%CI, 0.74-1.54) and 1.49 (95%CI, 0.71-3.11) respectively. Evidence from this large study suggests that metformin does not increase the risk of birth defects in children of women treated with metformin in early pregnancy for pregestational diabetes and that the underlying disease appears to play an important role in the occurrence of birth defects.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02986770
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Submitted on : Tuesday, November 3, 2020 - 11:37:35 AM
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Amelle Mouffak. Sécurité d’utilisation de la metformine au cours de la grossesse : étude pharmaco-épidémiologique à partir du système national des données de santé. Sciences pharmaceutiques. 2020. ⟨dumas-02986770⟩

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