Gestational diabetes mellitus.
Conditions
Interventions
Intervention 1: In metformin group, Metformin was started at a dose of 1000 mg once daily and increased, typically over a period of two weeks, to meet glycemic targets up to a maximum daily dose of 15
Treatment - Drugs
In metformin group, Metformin was started at a dose of 1000 mg once daily and increased, typically over a period of two weeks, to meet glycemic targets up to a maximum daily dose of 1500 mg. Plasma gl
In insulin group, insulin was administered with an initial dose of 0.2 IU/kg/d and titrated to meet glycemic targets according to usual practice. Plasma glucose target levels were defined as fasting b
Sponsors
Isfahan University of Medical Sciences, Vice-Chancellery for Research
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Control of maternal hyperglycemia. Timepoint: During Pregnancy every 2 weeks. Method of measurement: Measuring fasting blood sugar and blood sugar 2h pst prandial. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSafie Eshaghiyan
Isfahan University of Medical Sciences, Department of Obstetric and Gynecology
Outcome results
None listed