Common complaints in the first trimester of pregnancy.
Conditions
Interventions
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
Sponsors
Gonabad University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 eq | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAsma Salar
Gonabad University of Medical Sciences
Outcome results
None listed