]>
IRCT20200608047701N1 IRCT 2020-06-26 Kashan University of Medical Sciences The effect of Selenium supplementation in high risk mothers for Preeclampsia screened with Quadruple tests The effect of Selenium supplementation on clinical outcomes of Preeclampsia, metabolic profiles, and Pulsatility Index (PI ) of uterine artery in Doppler sonography in high risk mothers screening with Quadruple tests 2020-07-20 anticipated 60 Complete https://irct.ir/trial/48868 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using Stat Trek software and based on random number methods.In this method, the computer selects random numbers. Accounting is done by considering numbers for two groups.For example, even numbers will be in the intervention group and individual numbers will be in the control group, Blinding description: Randomization and random allocation of researchers and participants in the study will remain hidden until the completion of statistical analysis.Another person in the clinic, who has no role in this clinical trial and is unaware of the random allocation, will assign the numbered bottles of the capsules to the study participants.Patients and researchers are unaware of the type of intervention, and after analyzing the data, the package codes are decrypted . 2 Pre-eclampsia. Intervention 1: Intervention group:200 micrograms of selenium capsules (Alpha Vitamins , Arian Sena , Tehran , Iran),1 daily, orally for 12 weeks . Intervention duration: 12 weeks . Intervention 2: Control group: Selenium placebo capsules (Barij Essence , Kashan , Iran) , 1 daily, orally for 12 weeks. Intervention duration: 12 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 There is no further information.
public Farah Shahin
Qutb Ravandi Boulevard , Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 farahshahin660@yahoo.com Kashan University of Medical Sciences scientific Farah Shahin
Qutb Ravandi Boulevard , Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 farahshahin660@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) High-risk pregnant women for pre-eclampsia screened with Quadruple tests Age of 18 to 40 Pregnant woman living in Kashan First pregnancy Single pregnancy Lack of bone and chromosomal abnormalities Complete the consent form 18 years 40 years Female Lack of willingness to cooperate at any stage of the project Under age of 18 years old Pregnant women who are currently smoking (Low risk for preeclampsia ) Pregnant women who are taking selenium supplements Pregnant women who are taking thyroid medication Pregnant women who are taking Aspirin , Heparin or Anti hypertensive drugs Pregnant women who have chronic proteinuria Abnormal scan anomalies O14 Pre-eclampsia Treatment - Drugs Placebo Intervention group:200 micrograms of selenium capsules (Alpha Vitamins , Arian Sena , Tehran , Iran),1 daily, orally for 12 weeks . Intervention duration: 12 weeks . Control group: Selenium placebo capsules (Barij Essence , Kashan , Iran) , 1 daily, orally for 12 weeks. Intervention duration: 12 weeks . Highly sensitive C-reactive protein (Hs-CRP). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Eliza Kit. Systolic and diastolic blood pressure levels. Timepoint: At the beginning of the study and then twice a week. Method of measurement: Mercury sphygmomanometer. Nitric Oxide. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Total antioxidants. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Malone De Aldeid. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Pulsatility Index of Uterine artery. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Caller Doppler ultrasound. Serum hemoglobin. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: laboratory kit. Serum Platelet. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: laboratory kit. Liver transaminases. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: laboratory kit. Serum Creatinine. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: laboratory kit. Serum Uric acid. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: laboratory kit. Body Mass Index ( BMI ). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Weight by scales , Height by meter. Urinary protein excretion. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Urine sample. Kashan University of Medical Sciences Approved 2020-05-18 Ethics Committee of Kashan University of Medical Sciences Qutb Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)