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IRCT20220410054469N1 IRCT 2022-05-14 Shahid Beheshti University of Medical Sciences The effect of Aspirin in preventing preeclampsia Comparison of the effect of Aspirin at a dose of 160 mg per day with the usual dose of Aspirin (80 mg daily) in the prevention of preeclampsia in high-risk pregnant women 2022-06-22 anticipated 216 Complete https://irct.ir/trial/63036 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization of an individual using the rand function of EXCEL software. In this method, each person is assigned a number and based on software randomization, each person enters one of two groups, Blinding description: In this study, the patient and the researcher themselves were unaware of which control group (receiving the current routine drug, ie, 80 mg of aspirin daily) or intervention (receiving the dose of 80 mg of aspirin per day) belonged. For this purpose, patients in the control group are given two similar pills, one of which is a placebo. 2-3 Pre-eclampsia. Intervention 1: Intervention group 1: Pregnant women in the 12-20 weeks of pregnancy who are at high risk of preeclampsia are treated with aspirin at a dose of 160 mg daily for 36 weeks. Aspirin tablets are provided by Sami Saz Company and are prescribed to patients. One 160 aspirin tablet is proscribed a day. Intervention 2: Control group: Pregnant women who are prescribed aspirin 80 mg daily until the 36th week of pregnancy due to risk factors from 12-20 weeks of pregnancy. Aspirin 80 mg tablets are provided daily. Yes - There is a plan to make this available What will be shared: inclusion population and main outcome data When: Six months after the official release of the results To whom: Researchers, academics and industrial sectors Conditions: The data will be used in meta-analysis research. Where to obtain: Applicants can request the data by sending an email to Dr. Paria Panahinia. drpariapanahinia@yahoo.com How to obtain: While introducing themselves and explaining the need for access, data will be sent to them within 10 days to 1 month. Comments:
public Paria Panahinia
Mahdiyeh Hospital, Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 drpanahinia@yahoo.com Shahid Beheshti University of Medical Sciences scientific Paria Panahinia
Mahdiyeh Educational Hospital, Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq.
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 drpanahinia@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Pregnant women at 12-20 weeks of gestation at high risk for Preeclampsia. 18 years no limit Female Patients who find it difficult to follow a regular pattern of medication. Patients with heart, liver, thyroid, peptic ulcer diseases and bleeding disorder. Patients with a history of asthma, aspirin sensitivity, and the presence of major fetal disorders. O14 Pre-eclampsia Prevention Prevention Intervention group 1: Pregnant women in the 12-20 weeks of pregnancy who are at high risk of preeclampsia are treated with aspirin at a dose of 160 mg daily for 36 weeks. Aspirin tablets are provided by Sami Saz Company and are prescribed to patients. One 160 aspirin tablet is proscribed a day. Control group: Pregnant women who are prescribed aspirin 80 mg daily until the 36th week of pregnancy due to risk factors from 12-20 weeks of pregnancy. Aspirin 80 mg tablets are provided daily. Incidence of Preeclampsia. Timepoint: From 12-20 to 36 weeks of pregnancy. Method of measurement: Mercury sphygmomanometer / laboratory abnormalities (including doubling of liver enzymes, doubling of serum creatinine and drop in platelets below 100,000). Type of delivery (cesarean section or vaginal). Timepoint: Time of delivery. Method of measurement: Based on medical file and disease progression. Term or preterm delivery. Timepoint: Time of pregnancy termination. Method of measurement: Based on medical file and disease progression. Shahid Beheshti University of Medical Sciences Approved 2022-01-22 Ethics committee of Shahid Beheshti University of Medical Sciences Tehran, Evin, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)