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IRCT20220817055738N1 IRCT 2022-10-04 Shahid Beheshti University of Medical Sciences Comparison of the therapeutic effect of metformin and insulin in diabete Comparison of Pregnancy outcomes in women with gestational diabetes treated with metformin and insulin 2020-09-22 anticipated 100 Complete https://irct.ir/trial/65386 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were selected by simple random sampling method and divided into study groups using the table of random numbers.To use the table of random or random numbers, we first defined the framework of our statistical society; That is, we found out the exact number of people in the society and gave them a code or machine gun number respectively. To select sample people from the table, we randomly started from a point in the table in the row or column direction. After this, we checked the route numbers. We came across two types of numbers, one of which was smaller than the number of the studied community and the other was larger than the number of the community. We chose to consider only the smaller numbers.The selected number is actually the code of an individual from the community that is selected as a sample. We continued this work until we could choose a small number for the number of sample people. After the sample volume was completed, the sampling work was completed. 3 Gestational diabetes mellitus. Intervention 1: Intervention group 1: In the insulin group, if the fasting blood glucose was high, NPH insulin was prescribed at the rate of 0.2 units per kilogram before going to bed. If the postprandial blood glucose was high, regular insulin was given before meals based on the postprandial glucose level, at a rate of 1 unit for every 10 mg/dL above target. If both fasting and postprandial glucose levels were high, a total dose of 0.7 units/kg was started. Insulin was divided into two doses, morning and evening. The morning dose of two-thirds of NPH insulin was divided into one-third as regular insulin injection before meals if necessary, and at night, one-half of NPH and one-half of regular insulin. Adjustment of insulin dose depending on capillary blood glucose level was done based on four glucose measurements during the day. Intervention 2: Intervention group: The women in the metformin group received an initial dose of 500 mg twice a day, and it was increased by 500-1000 mg every two weeks in order to achieve the target blood sugar, and up to a maximum daily dose of 2500 mg in divided doses. increased in meals. Metformin was continued until delivery. If blood sugar control was not achieved despite the maximum dose of metformin, insulin was added. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Golshan Noorollahi
No 129، Golsar2 Ave، Keshavarz Blvd، Ardabil Town
Ardabil Iran (Islamic Republic of) 5615616419 +98 45 3379 0310 gnurollahiii@gmail.com Shahid Beheshti University of Medical Sciences scientific Golshan Noorollahi
No 129، Golsar2 Ave، Keshavarz Blvd، Ardabil Town
Ardabil Iran (Islamic Republic of) 5615616419 +98 45 3379 0310 gnurollahiii@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Fasting blood glucose (92-125 mg/dl),, 1-hour blood glucose ≥ 180 mg/dl after 75 grams of oral glucose 2-hour blood glucose (153-199 mg/dl) after 75 grams of oral glucose no limit no limit Female Women for whom metformin is contraindicated Diagnosed fetal anomaly Rupture of the fetal membrane at the time of entering the study Presence of any other medical condition O24.4 Diabetes mellitus arising in pregnancy Treatment - Drugs Treatment - Drugs Intervention group 1: In the insulin group, if the fasting blood glucose was high, NPH insulin was prescribed at the rate of 0.2 units per kilogram before going to bed. If the postprandial blood glucose was high, regular insulin was given before meals based on the postprandial glucose level, at a rate of 1 unit for every 10 mg/dL above target. If both fasting and postprandial glucose levels were high, a total dose of 0.7 units/kg was started. Insulin was divided into two doses, morning and evening. The morning dose of two-thirds of NPH insulin was divided into one-third as regular insulin injection before meals if necessary, and at night, one-half of NPH and one-half of regular insulin. Adjustment of insulin dose depending on capillary blood glucose level was done based on four glucose measurements during the day. Intervention group: The women in the metformin group received an initial dose of 500 mg twice a day, and it was increased by 500-1000 mg every two weeks in order to achieve the target blood sugar, and up to a maximum daily dose of 2500 mg in divided doses. increased in meals. Metformin was continued until delivery. If blood sugar control was not achieved despite the maximum dose of metformin, insulin was added. Blood sugar level. Timepoint: Fasting blood sugar and postprandial blood sugar of the participants were monitored weekly. A comparison of the blood sugar level measured with a glucometer and plasma blood sugar was made to check the accuracy of the stated blood sugar level. Method of measurement: Glucometer and plasma blood sugar. Shahid Beheshti University of Medical Sciences Approved 2022-04-16 Ethics Committee of Shahid Beheshti University of Medical Sciences No 129، Golsar 2 Ave، Keshavarz Blvd، Ardabil city Ardabil Ardabil Iran (Islamic Republic of)