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Study aim
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The effects of melatonin in high risk pregnant women receiving enoxaparin and aspirin
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 people. For randomization, block design is used.
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Settings and conduct
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Referred to the Imam Sajad hospital of Yasouj city in 2021, selection of 50 individuals based on inclusion and exclusion criteria, randomization into intervention and control groups, perform the intervention for 20 weeks, taking 5 cc of blood before the intervention and after the intervention.
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.
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Participants/Inclusion and exclusion criteria
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Inclusion: Pregnant women 15 to 45 years old؛ Gestational age between 6 to16 weeks؛ BMI more than 25 kg/m2
Exclusion: Chronic metabolic diseases؛ Smokers and alcoholics؛ Use of other dietary supplements and anti-inflammatory drugs؛ History of taking OCP pills؛ Twin pregnancies or more
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Intervention groups
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Intervention group: Two 3-mg melatonin tablets per day, 1h before bedtime for 20 weeks with 40 mg daily enoxaparin and 80 mg daily aspirin.
Control group: Two tablets of 3-mg placebo/day (containing starch), 1 h before bedtime for 20 weeks with 40 mg daily enoxaparin and 80 mg daily aspirin.
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Main outcome variables
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Serum levels of total antioxidant capacity؛ malondialdehyde؛ nitric oxide metabolites؛ sulfhydryl protein؛ C-reactive protein؛ baby weight؛ baby head circumference and baby height