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IRCT20121224011862N5 IRCT 2022-08-30 Vice chancellor for Research,Tabriz Effects of pravastatin on the prevention of preeclampsia in high-risk pregnant women Effects of pravastatin on the prevention of preeclampsia in high-risk pregnant women: arandomized controlled clinical trial 2022-09-01 anticipated 90 Complete https://irct.ir/trial/65246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are divided into two intervention groups using simple randomization method.The randomization method used in this study is the use of a table of random numbers.Random number table is a set of numbers that is generated without a specific pattern or order and they generated randomly and they are formed in a table.In first the direction of reading the numbers was specified.To read the numbers, random numbers are read from the left side of the table, then even numbers extracted from the table are allocated to control group and odd numbers extracted from the table are allocated to intervention group , Blinding description: Before prescribing the drug to the patient, the plan is introduced and written consent is received. Study at the outcome assessor level, and statistical analyzer of the results will be blinded.The possibility of blinding the patient and the doctor in order to respect the rights of the patients is not acceptable Because oral parvastatin tablets will be prescribed. The clinical caregiver of the patients, who is responsible for measuring and recording the blood pressure of the patients, will not know whether the patient is in the control or intervention group .Information forms with Group A and Group B headers will be delivered to the statistician for data analysis.The evaluator of the results of the study will also evaluate the groups as A and B and will be unaware of the type of intervention performed for each group. 3 Pre-eclampsia. Intervention 1: Control group: The group receiving routine prenatal care treatment. Intervention 2: Intervention group: In addition to receiving routine prenatal care, the intervention group will receive a 10 mg paravastatin (Abourihan Pharmaceutical Company) tablet daily for 16 weeks after diagnosis. The required number of pills will be provided to the participants at each visit until the next visit. To ensure the use of pills, pregnant mothers in the intervention group will be given a checklist to mark the checklist after each use and to avoid daily forgetting of the pill. At the end of each week, participants will be contacted by phone about the correct use of the pills. Participants will be excluded from the study if the pills are taken irregularly. 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 decision will be made.
public Dr.Farnaz Sahaf
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Farnaz Sahaf
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Pregnant women at high risk for the possibility of preeclampsia Consent to participate in the study Pregnancy age 16 to 20 weeks Having minimum literacy Having a phone number to follow up History of preeclampsia in previous pregnancy In Vitro Fertilization (IVF) Family history of preeclampsia BMI 35 and above Age over 40 years 18 years 45 years Female Uso de anticoagulantes, excepto aspirina. History of allergy to statins Multiple pregnancy History of thrombophilia Chronic kidney disease Autoimmune disease Cardiovascular diseases Smoking and alcohol consumption O14 Pre-eclampsia Treatment - Drugs Treatment - Drugs Control group: The group receiving routine prenatal care treatment Intervention group: In addition to receiving routine prenatal care, the intervention group will receive a 10 mg paravastatin (Abourihan Pharmaceutical Company) tablet daily for 16 weeks after diagnosis. The required number of pills will be provided to the participants at each visit until the next visit. To ensure the use of pills, pregnant mothers in the intervention group will be given a checklist to mark the checklist after each use and to avoid daily forgetting of the pill. At the end of each week, participants will be contacted by phone about the correct use of the pills. Participants will be excluded from the study if the pills are taken irregularly. Preeclampsia. Timepoint: before the intervention (16 weeks of pregnancy), then in the second visit (20 weeks of pregnancy), the third visit (24 weeks of pregnancy), the fourth visit (28 weeks of pregnancy), the fifth visit (30 weeks of pregnancy), sixth visit 32th week of pregnancy), seventh visit (34 th week of pregnancy) and eighth visit (38-40 th week of pregnancy). Method of measurement: mercury sphygmomanometer with a suitable cuff from the right arm in a sitting position after 15 The minute of rest. Vice chancellor for Research,Tabriz Approved 2022-06-01 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor; Central Building of Number2; Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)