Comparison of the Effectiveness of l_arginine plus aspirin with aspirin alone in preventing adverse outcomes in pregnant women at high risk of preeclampsia

Determining the effect of L-arginine with aspirin and aspirin alone in preventing adverse outcomes in pregnant mothers with high risk of preeclampsia

Clinical trial with a control group, triple blind, randomized, phase 3 on 90 patients. Randomization is done by Permuted block randomization method.

Identifing pregnant women referred to the Beheshti clinic in Kashan during the years 2022-2023, at risk of pre-eclampsia with gestational age 28-12 weeks. Allocating them in two groups by random block method and using Random generator software. Both groups will receive drug in the same packaging, size and box. The codes will be left with one of the collaborators of the research project and will be decoded at the end. None of the presenters and patients have any knowledge of the type of codes of each patient until after the data analysis, thus it is triple blind.

Pregnant women at risk of pre-eclampsia include: previous history of pre-eclampsia in the individual or first-degree family, autoimmune disease, diabetes, chronic hypertension, age over 35 years, and body mass index greater than 30; nulligravida; multiple pregnancy; lipid disorders and age of 12 to 28 weeks of pregnancy will be included in the study.The presence of drug sensitivity to aspirin or L-arginine, or the presence of any fetal disorder or contraindication to continue the pregnancy, will be excluded from the study.

L-arginine 1000 mg daily with Aspirin 80 mg were prescribed in the intervention group from 12 to 28 weeks until the end of pregnancy, and in the control group aspirin 80 mg daily with placebo will be prescribed, thus the effect of L-arginine will be investigated in comparison with placebo.

Pregnancy complications; preeclampsia; post partom hemorrhage; preterm delivery; placental abruption

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.

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.