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IRCT20221108056440N1 IRCT 2022-11-27 Kashan University of Medical Sciences Comparison between L-arginine and aspirin and aspirin alone in preventing preeclampsia in high-risk pregnant women. Comparison of the Effectiveness of l_arginine plus aspirin with aspirin alone in preventing adverse outcomes in pregnant women at high risk of preeclampsia 2022-11-22 anticipated 90 Complete https://irct.ir/trial/66787 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Permuted block randomization, Randomization description: Permuted block randomization: all the 4 blocks containing two letters A and B are prepared (6 blocks) and we assign a number from 1 to 6 to each of them. Then, using the table of random numbers, numbers one to six are selected (24 numbers) and the corresponding block will be written based on the selected random number. With this, a sequence of 90 letters A and B will be obtained. Each of the samples will have a number from 1 to 90 when introducing the study, and based on each person's number, they will receive an A or B code based on the list of letters. This is done randomly and both groups will be almost the same. Group A was assigned to the group receiving L-arginine and aspirin by simple random method, and group B was assigned to the group receiving aspirin and placebo. With this method, 45 patients are placed in each group, Blinding description: Both groups receive drugs in the same package, size and box. The codes remain with one of the collaborators of the research project and will be decoded at the end of the study. None of the presenters and patients know the type of codes of each patient until after the data analysis, thus this study is conducted triple blinded. 3 Condition 1: Preeclampsia. Condition 2: Diabetes Mellitus. Condition 3: Hypertension. Intervention 1: Intervention group: L-arginine 1000 mg along with aspirin 80 mg will be prescribed once a day for pregnant women who are among the high-risk group for preeclampsia, . Intervention 2: Control group: In this group of pregnant women, who are among the high-risk group for eclampsia, aspirin 80 mg once a day will be routinely prescribed. 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 with cosideration of the drug expensiveness and the importance of the pregnancy period and the fear of the dangerousness and side effects of the drug, patients not cooperating and the desired result will not achieved.
public Hossein Akbary
5th Qotb_e Ravandi Ave., Kashan university of medical sciences, Kashan, IRAN
Kashan Iran (Islamic Republic of) 87159 88111 +98 31 5550021 akbari1350@yahoo.com Kashan University of Medical Sciences scientific Mesdaghinia Elahe
5th Qotb_e Ravandi Ave., Kashan university of medical sciences, Kashan, IRAN
Kashan Iran (Islamic Republic of) 87159 88111 +98 31 5510 3571 mesdaghiniaelaheh@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Pregnant women who are at high risk for preeclampsia Pregnant women with a gestational age between 14 and 28 weeks of pregnancy Previous history of pre-eclampsia in the individual or first degree relatives of the individual's sister or mother Women with a history of chronic hypertension Body mass index greater than 30 Multiple pregnancy Lipid disorders no limit no limit Female Drug sensitivity to L-arginine Drug sensitivity to aspirin O14 O24 I10 Pre-eclampsia Diabetes mellitus in pregnancy, childbirth, and the puerperium Essential (primary) hypertension Treatment - Drugs Treatment - Drugs Intervention group: L-arginine 1000 mg along with aspirin 80 mg will be prescribed once a day for pregnant women who are among the high-risk group for preeclampsia, . Control group: In this group of pregnant women, who are among the high-risk group for eclampsia, aspirin 80 mg once a day will be routinely prescribed Blood Pressure. Timepoint: During the first appointments and at each pregnancy care visit (for visits during pregnancy, it is once a month from the first week to 28 weeks, and every two weeks from 28 to 36 weeks and then weekly examination until the end of pregnancy). Method of measurement: The percentage of people with blood pressure above 90.140 mm Hg. Preeclampsia. Timepoint: From the 20th week of pregnancy during any pregnancy care as discussed above or if there are any signs and symptoms of preeclampsia from the 20th week onwards. Method of measurement: Checking blood pressure and other signs and symptoms of pre-eclampsia, including headache, blurred vision, chest pain or laboratory disorders such as thrombocytopenia or increased liver enzymes or increased creatinine. Termination of pregnancy (term or pre-term). Timepoint: At the end of pregnancy. Method of measurement: With the birth of a baby and during childbirth. IUGR. Timepoint: During pregnancy care, especially during the 28th till 32nd weeks and at the time of birth. Method of measurement: Measurement of fetal weight and growth during pregnancy and birth weight. Pregnancy complication. Timepoint: During pregnancy and childbirth. Method of measurement: Examination in terms of the amount of bleeding, meconium, decollement, stillbirth, preterm labour. Kashan University of Medical Sciences Approved 2022-11-01 Ethics committee of Kashan University of Medical Sciences Parastar Ave., 5th of Qotb_e Ravandi Blvd., Kashan, IRAN Kashan Isfehan Iran (Islamic Republic of)