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Metformin for gestational diabetes mellitus

Not Applicable
Conditions
Gestational diabetes mellitus.
Registration Number
IRCT201306057841N4
Lead Sponsor
Isfahan University of Medical Sciences, Vice-Chancellery for Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
100
Inclusion Criteria

1) 18-45 years aged; 2) pregnancy with a single fetus between 24 and 33 weeks of gestation; 3) current diagnosis of gestational diabetes mellitus according to the criteria of the Australasian Diabetes in Pregnancy Society (ADIPS); 4) no response to lifestyle modification (diet and exercise) after one week; 5) written informed consent. Exclusion criteria: 1) any contraindication for receiving metformin (renal or hepatic failure); 2) any history or documented diagnosis of diabetes prior to pregnancy; 3) history of sever drug reaction to the drugs in study; 4) any serious medical condition that may interfere with safe study participation

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hyperbilirubinemia. Timepoint: During the first two hours post partum. Method of measurement: Measuring blood bilirubin.;Pregnancy Induced Hypertention. Timepoint: During pregnancy every 2 weeks. Method of measurement: Measuring blood pressure.;Neonatal hypoglycemia. Timepoint: During the first two hours post partum. Method of measurement: Measuring blood sugar.;Preterm labor. Timepoint: During pregnancy every 2 weeks. Method of measurement: Evaluating symptoms of preterm labor by physical examination and history taking.;Birtth weight. Timepoint: During the first two hours post partum. Method of measurement: Measuring Neonatal weight.;Respiratory Distress Syndrom. Timepoint: During the first two hours post partum. Method of measurement: Physical examination.
Secondary Outcome Measures
NameTimeMethod
Control of maternal hyperglycemia. Timepoint: During Pregnancy every 2 weeks. Method of measurement: Measuring fasting blood sugar and blood sugar 2h pst prandial.
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