Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus

Summary

Participation Requirements

Description

Prospective, multicenter, superiority, randomised, double blind study with two arms. In the 11 participating centers (9 in France and 2 in Belgium): selection of women with GDM between 12 and 34 weeks of gestation Explanation of protocol, with signature of consent in case of acceptation. Randomizati...

Prospective, multicenter, superiority, randomised, double blind study with two arms. In the 11 participating centers (9 in France and 2 in Belgium): selection of women with GDM between 12 and 34 weeks of gestation Explanation of protocol, with signature of consent in case of acceptation. Randomization Experimental group: The women will receive 2 caps of MI with acid folic a day, until delivery Control group: The women will receive 2 caps of placebo (containing only acid folic) a day, until delivery In both arms, the participants will be routinely followed up during pregnancy: diet education, self-monitoring of blood glucose before and after meals and during follow-up insulin therapy if glucose value targets are unmet Routine monitoring of the women with GDM in both arms, up to delivery, without use of other oral hypoglycemic agents during pregnancy. At delivery: MI (or placebo) will be stopped Maternal blood samples will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement, when the women are perfused and cord fluid will be collected at the same as cord fluid pH is routinely measured just after delivery. The aliquots will be transported to the "Centre de Ressources Biologiques"(CRB) of the Jean Verdier Hospital Events during pregnancy will be collected Last visit three months after delivery. Oral glucose tolerance test, anthropometric measures for women and their child.

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