Evaluation of the effect of metformin and insulin combination therapy in comparison with the use of insulin alone in the prevention of preeclampsia in pregnant women with gestational diabetes

The effect of metformin 500milligram and insulin compared to the use of insulin in prevention of preeclampsia in pregnant women with gestational diabetes

Clinical trial with control group, with parallel groups, randomized, on 150 patients. The rand function of Excel software was used for randomization.

This study will be conducted on 150 pregnant women with gestational diabetes referring to Alzahra, Shahid Beheshti and Amin hospital. After entering the study, patients are divided into intervention and control groups using a simple randomization method. Patients in the control group will be treated with insulin using a Intermediate-acting insulins such as neutral protamine Hagedorn with a starting dose of 2 units per kilogram, and in the intervention group, they will be treated with metformin and insulin, metformin 500 milligram twice a day.

Inclusion criteria: Gestational diabetes mellitus based on glucose challenge test or glucose tolerance test , age of 18-40 years, single pregnancy, gestational age between 20-34 weeks and fasting glucose testing over 95 milligram per deciliter or 2 hours postprandial blood sugar glucose over 120 milligram per deciliter Exclusion criteria: high blood pressure before pregnancy, history of any systemic disease (including cardiovascular, kidney Diseases, hepatic and autoimmune diseases), Addiction or drug abuse, Obesity (Body mass index above 30), overt diabetes, major neonatal malformations

Patients in the intervention group will receive oral metformin 500 milligram twice a day and insulin according to the patient's needs until the day of delivery or termination of pregnancy. Patients in the control group will receive oral metformin 500 milligram twice a day until the day of delivery or termination of pregnancy

Symptoms of Preeclampsia

Patients are divided into two equal intervention and control groups by simple randomization method and using Rand function of Excel software. In this way, we type the expression (0,1)randbetween= in one of the cells of the Excel software, if the random number generated was 0, it is from insulin treatment alone, and if the number was observed, it was 1 from the combination treatment of metformin and insulin. We use and continue this work until all 150 patients are assigned to two intervention and control groups.

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