IRCT20210608051518N1 IRCT 2021-12-22 Yasouj University of Medical Sciences The effects of melatonine in high risk pregnant women receiving enoxaparin and aspirin The effects of melatonine on the levels of oxidative stress and inflammatory markers in high risk pregnant women receiving enoxaparin and aspirin 2022-01-05 anticipated 50 Complete https://irct.ir/trial/60425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size, blocks will be generated using the online site (www.sealedenvelope.com). Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable, Blinding description: For blinding and unawareness of doctor, researcher, and individuals, unique codes will be used on the drug boxes. Melatonin and placebo tablets will be placed into identical containers by an independent third party. Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable. 2-3 High risk pregnant women receiving prophylaxis enoxaparin and aspirin. Intervention 1: Intervention group: Two 3-mg melatonin tablets per day, 1 h before bedtime for 20 weeks, made by Nature Made, USA with 40 mg daily enoxaparin and 80 mg daily aspirin. Intervention 2: Control group: Two tablets of 3-mg placebo/day (containing starch), 1 h before bedtime for 20 weeks, provided by the school of Pharmacy at Yasuj University of Medical Sciences with 40 mg daily enoxaparin and 80 mg daily aspirin. No - There is not a plan to make this available Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics