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IRCT20210316050725N1 IRCT 2021-05-28 Iran University of Medical Sciences The effect of the metformin in preventing of the preeclampsia Evaluation of the effect of metformin in prevention from severe preeclampsia 2021-06-05 anticipated 52 Complete https://irct.ir/trial/55106 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After determining the total volume of the sample.papers A and B are placed in the lottery container. Then the papers are randomly removed from the container without replacement and the created sequence is recorded, Blinding description: The person receiving the medication, the person giving the medication, and the person analyzing the results are unaware of the type of medication (metformin or placebo) used. Placebo (paper A) and metformin tablets (paper B) are poured in equal numbers in a bag. and at the time of the patient's visit who are eligible for the study, she is said to have picked up one of the papers. pills then given to the patient based on the patient's choice (blind) . (the resident who gives the pill does not know which group of placebo and which group is metformin due to the same packaging. she is blind .). The analyzer also reports the final results under groups A and B (without knowing the type of group). 3 Non severe preeclampsia. Intervention 1: In the intervention group, pregnant woman with only high blood pressure is given 1000 mg of metformin during her entire pregnancy, and during the course of labor, the symptoms of severe preeclampsia and fetal growth are evaluated. Intervention 2: In the control group, pregnant woman with only high blood pressure is given a placebo for the entire pregnancy and the symptoms of severe preeclampsia and fetal growth are assessed during labor. Yes - There is a plan to make this available What will be shared: paper When: one months after paper print To whom: all people Conditions: Email Where to obtain: Demandants can contact by Dr. Shahnaz Ahmadi, the principal investigator, or the education office of Akbrabadi Hospital via the email ahmadishahnaz2005 @ yahoo.com and call 02155633244 How to obtain: respose one month after email Comments:
public Shahnaz Ahmadi
Molavi street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5563 3244 Ahamdishahnaz2005@yahoo.com Iran University of Medical Sciences scientific Shahnaz Ahmadi
Molavi Street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5563 3244 Ahmadishahnaz2005@yahoocom Iran University of Medical Sciences Iran (Islamic Republic of) Non severe preeclampsia Single pregnancy no limit no limit Female Eclamsia Severe reeclamsia Renal failure Insulin -treated diabet O14.00 Mild to moderate pre-eclampsia, unspecified trimester Treatment - Drugs Treatment - Drugs In the intervention group, pregnant woman with only high blood pressure is given 1000 mg of metformin during her entire pregnancy, and during the course of labor, the symptoms of severe preeclampsia and fetal growth are evaluated In the control group, pregnant woman with only high blood pressure is given a placebo for the entire pregnancy and the symptoms of severe preeclampsia and fetal growth are assessed during labor. Severe preeclampsia. Timepoint: Weekly untill term pregnancy. Method of measurement: Weekly visit , blood pressure assesment , laboratory assesment. Hypertension. Timepoint: Weekly visit. Method of measurement: with the help of mercury manometer. Fetal growth. Timepoint: Weekly. Method of measurement: Ultrasound. Elevated in liver enzyme. Timepoint: Weekly. Method of measurement: Laboratory. Headache, blurred vision , pain in epigaster. Timepoint: weekly. Method of measurement: Biography. Blood creatinine in mother. Timepoint: Weekly. Method of measurement: Laboratory. Diabet in mother. Timepoint: Monthly. Method of measurement: Assesment of Fast blood sugar and 2 hours after meal. Fetal health assessment tests. Timepoint: Weekly. Method of measurement: Non stress test and biophysical profile. Proteinurea. Timepoint: Weekly. Method of measurement: By collecting urine 24 hours a day. Iran University of Medical Sciences Approved 2020-01-28 Ethics committee of Iran university of medical science Molavi Street Tehran Tehran Iran (Islamic Republic of)