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IRCT20200113046112N1 IRCT 2020-03-17 Oroumia University of Medical Sciences Prophylactic properties of metformin in the prevention of gestational diabetes mellitus Assessing the efficacy of the prophylactic metformin administration in the prevention of gestational diabetes mellitus in non-diabetic obese pregnant women referred to Motahari Teaching Hospital 2020-01-18 anticipated 342 Complete https://irct.ir/trial/45620 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization will be performed to stratify patients into two groups: intervention and control. Each block will include 6 patients. All possible combinations of AAABBB will be listed and coded individually. Considering a study population of 342 patients, randomization of patients into 57 blocks is required. Blocks will be assigned to either groups in an alternating order. 3 Gestational Diabetes Mellitus in obese pregnant women. Intervention 1: Administration of metformin(as F.C.Tablets metformin hydrochloride, manufactored in Iran, Kharazmi/ 500 mg every 12 hours; oral) starting from the 12th week of pregnancy until the time of delivery. Intervention 2: Control group: They will not be prescribed medication and will undergo routine pregnancy care and follow-up. 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 After the completion of the project, the descicion will be made
public Shiva Ghayor
Kashani Ave., Motahari Hospital
Urmia Iran (Islamic Republic of) 04412234125 +98 44 3223 7078 sh.ghayor90@gmail.com Oroumia University of Medical Sciences scientific Shiva Ghayor
Kashani Ave., Motahari Hospital
Urmia Iran (Islamic Republic of) 04412234125 +98 44 3223 7078 sh.ghayor90@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age >16 years Gestational age <3 months Singleton pregnancy Body mass index ≥30 16 years no limit Female Multifetal pregnancy Fetal anomaly Previous history of diabetes mellitus, gestational diabetes mellitus, impaired fasting glucose or impaired glucose tolerance test History of corticosteroid use Heavy alcoholism History of adverse or allergic reactions to metformin History of underlying medical conditions (e.g. hypertension, renal failure, liver disease, malabsorption) Prevention Early detection Administration of metformin(as F.C.Tablets metformin hydrochloride, manufactored in Iran, Kharazmi/ 500 mg every 12 hours; oral) starting from the 12th week of pregnancy until the time of delivery Control group: They will not be prescribed medication and will undergo routine pregnancy care and follow-up. Incidence of gestational diabetes mellitus. Timepoint: Between weeks 24 and 28 of pregnancy. Method of measurement: Through the performance of two-hour glucose tolerance test with 75 grams of glucose. Requirement of insulin administration in the setting of gestational diabetes mellitus. Timepoint: Since the 24th week of pregnancy until time of delivery. Method of measurement: Questionnaire. Final dosage of administered insulin at the time of delivery. Timepoint: One day prior to delivery. Method of measurement: Patient documentations. The incidence of polyhydramnios. Timepoint: Final pregnancy trimester. Method of measurement: Ultrasound imaging. Incidence of preterm labor. Timepoint: At the time of delivery. Method of measurement: Assessment of gestational age will be performed based on ultrasound imaging and previously documented data pertaining to the current pregnancy. Frequency of performed Cesarean Sections. Timepoint: At the time of delivery. Method of measurement: Hospitalization documents or by researcher designed questionnaire. Frequency of hospitalization at the neonatal intensive care unit. Timepoint: At the time of birth. Method of measurement: Researcher designed questionnaire or hospitalization documentations. Oroumia University of Medical Sciences Approved 2020-01-01 Ethics committee of Urmia University of Medical Sciences orjhans Ave., Resalat Blvd Urmia West Azarbaijan Iran (Islamic Republic of)