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IRCT20120215009014N416 IRCT 2022-01-12 Hamedan University of Medical Sciences Effect of L-arginine versus control group on the prevention of preeclampsia in primiparous pregnant women Effect of L-arginine versus control group on the prevention of preeclampsia in primiparous pregnant women: a single-blind randomized controlled trial 2022-01-30 anticipated 172 Complete https://irct.ir/trial/61191 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group, Blinding description: The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single -blind. 3 Pre-eclampsia. Intervention 1: Intervention group: Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks plus L-arginine 500 mg tablets (manufactured by Karen Pharmaceutical Co.) from 20th weeks of pregnancy once a day for 12 weeks. Intervention 2: Control group: Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks. 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Dr. Shahedeh Khansari
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 dr_sh_kh@yahoo.com Hamedan University of Medical Sciences scientific Dr. Shahla Nasrolahi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 sh.nasrolahi@ yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 45 years; Primiparous: Singleton; Gestational age of 20 weeks; 18 years 45 years Female History of hypertension; Affected with chronic diseases such as thyroid disorder and diabetes; Using selenium supplement; O14 Pre-eclampsia Treatment - Drugs Treatment - Drugs Intervention group: Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks plus L-arginine 500 mg tablets (manufactured by Karen Pharmaceutical Co.) from 20th weeks of pregnancy once a day for 12 weeks Control group: Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks Preeclampsia. Timepoint: Every two weeks until the end of pregnancy. Method of measurement: By taking a history (headache, blurred vision, epigastric pain, seizures), clinical examination (hypertension) and laboratory methods (oliguria, proteinuria, and increased liver enzymes). Hamedan University of Medical Sciences Approved 2021-10-16 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)