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IRCT20190730044382N2 IRCT 2020-05-02 Gonabad University of Medical Sciences Effect of oral vitamin B6 on common complaints of first trimester pregnancy Effect of oral vitamin B6 on common complaints of first trimester pregnancy in women referred to community health centers in Gonabad in 2019-2020 2020-03-05 anticipated 72 Complete https://irct.ir/trial/45743 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For sampling, each person will be selected for inclusion in the study, and then the samples will be divided into two intervention groups (A (or control) B) based on 4-block design and random allocation. A 4-block block will be used for sampling (AABB, ABAB, BBAA, BABA), Blinding description: In this study vitamin B6 and placebo will be prepared in packages including 30 tablets as A and B. Due to the method of the study, the research unit and the researcher have no information about each package; it means that placebo (manufactured by Mashhad School of Pharmacy) and vitamin B6 tablets is provided in A and B packages that are completely similar. These packages are prepared by another person (not the researcher) then are given to the researcher. After explaining phases of the research to the research units and obtaining written consent will be placed in two groups of intervention and control based on random block allocation. 4-block packages will be used for sampling (AABB, ABAB, BBAA, BABA). 3 Common complaints in the first trimester of pregnancy. Intervention 1: Intervention group: Oral vitamin B6 tablet 40 mg, daily for 30 days Manufactured by Iran Hormone Company. Intervention 2: Control group: One 40 mg tablet containingstarch daily for 30 days, manufactured by Mashhad School of Pharmacy. 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 No more information
public Asma Salar
Emam Khomeiny
Gonabad Iran (Islamic Republic of) ۹۶۹۱۷۹۳۷۱۸ +98 51 5722 2598 asmasalar69@gmail.com Gonabad University of Medical Sciences scientific Asma Salar
Emam Khomeiny
Gonabad Iran (Islamic Republic of) ۹۶۹۱۷۹۳۷۱۸ +98 51 5722 2598 asmasalar69@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18-40 years Pregnancy age 6-10 weeks Low risk pregnancy Depression score less than 12 Lack of physical and mental illness Use supplements the first trimester of pregnancy (iodopholic and vitamin D3) No breastfeeding Knowing how to read and write Hemoglobin greater than 11 gr/d Breast pain with pregnancy starting for 5 days or more Pregnancy wanted No history of stillbirth No history recurrent abortion No history of infertility Do not used B6 supplementation before recent pregnancy Normal body mass index (18.5-24.9) No employment in night shift Sleep quality score of 5 or more Fatigue score greater than one Mild to moderate nausea and vomiting score (score 3-12) 18 years 40 years Female Not using vitamin B6 in intervention group Not using placebo in control group Abortion or medical termination of pregnancy Unwillingness to participate in follow-up study. Not filling questionnaires during the study Pregnancy twins or moles Receiving new medication during the study. Treatment - Drugs Placebo Intervention group: Oral vitamin B6 tablet 40 mg, daily for 30 days Manufactured by Iran Hormone Company Control group: One 40 mg tablet containingstarch daily for 30 days, manufactured by Mashhad School of Pharmacy. The effect of vitamin B6 on breast pain. Timepoint: Measurement of breast pain at the beginning and end of the study. Method of measurement: The Visual Analogue Scale Questionnaire is a standard instrument measuring a 10 cm ruler. Depending on the amount of pain, the person signs on the continuum for the past 48 hours. The Linear-Visual Measurement Scale of Pain is classified as 0 to 10 as follows: 0: No pain, 3-1: Mild pain, 4-6: Moderate pain, 10-7: Severe pain. The effect of vitamin B6 on depression score in pregnant women. Timepoint: At the beginning and end of the study. Method of measurement: The Edinburgh Depression Questionnaire is used to measure depression during pregnancy and postpartum. The tool has 10 four-choice questions and each question has a score of 0-3 and its overall score ranges from 0-30. In Iran, a score of 12 or higher is a sign of mothers' depression. The effect of vitamin B6 on sleep quality of pregnant women. Timepoint: At the beginning and end of the study. Method of measurement: Petersburg Sleep Quality Questionnaire (PSQI) One of the best tools designed to measure sleep quality is the Petersburg Sleep Quality Questionnaire (PSQI). The sum of the 7 subscale scores will be between 0 and 21. Getting a total score above 5 on the whole questionnaire means poor sleep quality. The effect of vitamin B6 on fatigue in pregnant women. Timepoint: At the beginning and end of the study. Method of measurement: Multidimensional Fatigue Scale (MAF) Questionnaire, which is used to measure fatigue and is capable of measuring fatigue in pregnant women. The effect of vitamin B6 on pregnancy nausea and vomiting. Timepoint: At the beginning and 4 days after the start of the study. Method of measurement: The 24-hour Pregnancy Nausea and Vomiting Questionnaire (PUQE-FORM-24) consisted of three questions that measured the duration of nausea, vomiting time, and frequency of frustration over the past 24 hours, with scores ranging between 15 and 3. Less than or equal to 6 indicates mild nausea and vomiting, moderate nausea and vomiting 7-12 and more or less than 13 severe forms. Gonabad University of Medical Sciences Approved 2020-02-02 Ethics committee of Gonabad University of Medical Sciences Asian Road Margin, Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)