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IRCT20140317017035N5 IRCT 2020-05-04 Shiraz University of Medical Sciences Comparison of the effect of two regimens of metformin and insulin on glucose tolerance test Comparison of pregnancy outcome and glycemic control between insulin versus insulin plus metformin in management of gestational diabetes. 2018-07-09 anticipated 80 Complete https://irct.ir/trial/47574 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use similar pocket, Blinding description: The study is a double-blind, so that the patient and the person providing the medication to the patient and the person analyzing the data do not know the type of treatment used for each person. 3 Gestational Diabetes. Intervention 1: Intervention group: In first group of intervention, if the blood suger is not controlled with diet. Initially, insulin will be started at 0.5_1 unit per kg, and then if it need, more glucophage (Actoverco factory) and insulin detemir will be added intermittently . The maximum dose of glucophage is up to 2000 mg. changes in oral and injectable medication will be continued for up to 36 weeks in permited manner, if its necessary . To minimize the hypoglycemic effect in infants the glucophage will reduce by one every 4 days from week 36 onwards. Intervention 2: Control group: In group two of intervention, if the blood suger is not controlled with diet. Initially, insulin will be started at 0.5_1 unit per kg, and then if it need, more insulin detemir will be added intermittently. Yes - There is a plan to make this available What will be shared: IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient When: IPD: 2019 Ethic form: 2019 To whom: IPD: Researcher & Patient Ethic form: Patient Conditions: IPD: Ethic form: Awareness of test results Where to obtain: IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences How to obtain: IPD: Vice chancellery Ethic form: Vice chancellery Comments:
public Azadeh Ghahartars
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3233 2365 Hafez_perina@sums.ac.ir Shiraz University of Medical Sciences scientific Maryam Kasraeian
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 maryamkasraeian@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Single-pregnancy Gestational age 20-34 weeks FBS is higher than 100 mg/dL Age range 18 to 40 years 18 years 40 years Female Diagnosis of pre-pregnancy diabetes, presence of metabolic disorders in the patient Need to start treatment with insulin in oral treatment patients Dissatisfied to cooperate in the study Metabolic disorder in the patient Gestational Hypertension O24.41 Gestational diabetes mellitus in pregnancy Treatment - Drugs Treatment - Drugs Intervention group: In first group of intervention, if the blood suger is not controlled with diet. Initially, insulin will be started at 0.5_1 unit per kg, and then if it need, more glucophage (Actoverco factory) and insulin detemir will be added intermittently . The maximum dose of glucophage is up to 2000 mg. changes in oral and injectable medication will be continued for up to 36 weeks in permited manner, if its necessary . To minimize the hypoglycemic effect in infants the glucophage will reduce by one every 4 days from week 36 onwards. Control group: In group two of intervention, if the blood suger is not controlled with diet. Initially, insulin will be started at 0.5_1 unit per kg, and then if it need, more insulin detemir will be added intermittently. Control of serum glucose level in pregnant women with gestational diabetes mellitus. Timepoint: On average checked twice at week 36. Method of measurement: Oral Glucose Tolerance Test. Blood sugar levels. Timepoint: 1 hour after birth. Method of measurement: Glucometer. Neonate weight. Timepoint: After birth. Method of measurement: scale. Apgar score. Timepoint: First and fifth minutes after birth. Method of measurement: Apgar score scale. Shiraz University of Medical Sciences Approved 2018-07-07 Ethics Cmmittee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz Shiraz Fars Iran (Islamic Republic of)