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Study aim
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The effect of vitamin C supplementation in the last month of pregnancy on neonatal bilirubin level
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Design
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This study was a clinical trial and included two intervention and control groups that were randomly assigned to four blocks.
This study is a three-blind type.
Based on previous studies, the reported standard deviation for bilirubin was 3.5 to 4.5. Therefore, in this study, taking into account the probability of the first type error of 5% and the second type error of 20%, the mean difference between the two groups was equal to 2 mg / dl and the standard deviation of 4 mg / dl, the sample size was 64 in each group It was found that by assuming a 10% drop, 72 people in each group were considered.
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Settings and conduct
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144 healthy pregnant women who are 34 weeks pregnant will be randomly selected from among referrers to Qom health centers and divided into two groups of 72 intervention and control groups. Pregnancy is commonly administered to both groups in the same way, and the multi-vitamin mineral and iron supplementation is prescribed for both groups similar to other pregnant women and according to the instructions of the health center, but the intervention group from the beginning of the 35th week to the end A pregnant woman will receive a 500 mg vitamin C tablet that is manufactured by Oswah and will give the control group a placebo.
Since prenatal care is normally done at weeks 36 and 37 to 39, each pill needs to be delivered to the attendant at each visit, and to ensure that the pills are present in the referral. The next packets will be empty. If the baby is born earlier than the 37th week (preterm), the study will be discontinued.
Neither we (the researcher nor the statistician) nor the participants will know about which of the people, supplements or placebo are used (a triple blind study).
At the end of the infant, the infants will be under the supervision of a neonatal specialist and based on the coordination of the blood sample taken from the heel of the infants on the fifth day (jaundice, caused by physiological failure in term neonates) routinely screened for All infants will be taken to determine the level of bilirubin.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria :
Age range 20 to 40 years ؛ Being on the 34th week of pregnancy ؛ Single pregnancy ؛ Willingness to participate in research and signing consent.
Non-entry criteria:
pregnancy-related illnesses such as gestational diabetes, gestational hypertension, or hypothyroidism in pregnancy ؛ Having severe anemia ؛ Hepatic Diseases ؛ Renal diseases ؛ birth history of premature and low birth weight ؛
Family history of favism ؛ lactation at the same time as pregnancy ؛ use of aspirin and anticoagulants ؛ smoking.
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Intervention groups
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We will have two intervention groups. A group of 72 people who will receive a supplement of 500 milligrams of vitamin C from the beginning of the 35th week until the end of pregnancy, and 72 patients in the placebo group will recieve a 500 mg starch tablet from the beginning of the 35th week to the end of pregnancy.
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Main outcome variables
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Neonatal blood bilirubin level