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Gestational Diabetes in Non Obese Women and Metformine

ClinicalTrials.gov · TERMINATED, 2018

84 participants

Abstract

Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. Usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some studies have shown the comparable effect of metformin and insulin in about 50% of GD obese patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. In case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.

Conditions: Gestational Diabetes, Metformin, Treatment, Oxidative Stress.

Primary outcome: Efficacy of metformin in treatment of gestational diabetes based on capillary glycaemia with an objective of less than 6 measures out of range.

Enrollment: 84 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 84 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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