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IRCT20140317017035N7 IRCT 2020-11-28 Shiraz University of Medical Sciences Effect of Aspirin on on maternal and fetal factors Comparison of the effect of 80 and 150 mg aspirin on maternal and fetal factors in first trimester of pregnancy in women who is high risk for preeclampsia in patients referred to teaching hospitals of Shiraz University of Medical Sciences 2020-12-10 anticipated 100 Complete https://irct.ir/trial/52425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In our research, we will select 100 high risk pregnant women for preterm severe preeclamsia & GDM based on first trimester doppler sonography, then with block randomizing method with 4th and 6th block, we will place them on two groups. 50 patient will receive 80 mg aspirin and other group will receive 150 mg aspirin. Treatment starts since 11-13 week of pregnancy until 34 week or delivery time(each one occur sooner.), Blinding description: All tablet use in two groups are the same shape, color and size. Patients and doctors are unaware about dosages that is chosen in each person. The nurse of research center has the list of randomized and grouping and tablets and she will give drugs to the patients. 3 Severe preeclampsia. Intervention 1: Intervention group: 50 person will receive 80 mg aspirin untill 34 weeks. Intervention 2: Intervention group: 50 person will receive 150 mg aspirin untill 34 weeks. Yes - There is a plan to make this available What will be shared: IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient When: IPD: 2020Ethic form: 2020 To whom: IPD: Researcher & Patient Ethic form: Patient Conditions: IPD: Ethic form: Awareness of test results Where to obtain: IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences How to obtain: IPD: Vice chancellery Ethic form: Vice chancellery Comments:
public Sydeh Fateme Khaleghi
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3233 2365 alifatijoon1396@gmail.com Shiraz University of Medical Sciences scientific Maryam Kasraeian
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 maryamkasraeian@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The singleton pregnant women who are high risk for uteroplacental preeclamsia and GDM based on increased uterine artery resistant on first trimester doppler ultarasonography. 18 years 40 years Female Multiple pregnancy Fetal aneuploidy Fetal anomaly Coagulation disorder Allergy to aspirin Women who use aspirin or heparin before starting study JA24 Pre-eclampsia Treatment - Drugs Treatment - Drugs Intervention group: 50 person will receive 80 mg aspirin untill 34 weeks Intervention group: 50 person will receive 150 mg aspirin untill 34 weeks. Decrease fetal mortality and morbidity due to preeclampsia. Timepoint: َAfter birth. Method of measurement: Vital Signs. Shiraz University of Medical Sciences Approved 2020-02-22 Ethics Cmmittee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz Shiraz Fars Iran (Islamic Republic of)