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IRCT20240107060642N1 IRCT 2024-01-30 Gonabad University of Medical Sciences Investigating the effect of folic acid supplementation on postpartum depression in women Investigating the effect of folic acid supplementation on postpartum depression in women referring to comprehensive health service centers in Mashhad and Gonabad in 2014-2014 2024-01-20 anticipated 60 Complete https://irct.ir/trial/74895 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done by the available method and using random allocation in two groups. Sampling method: multi-stage. First, the list of all the centers is prepared according to the 13 regions of Mashhad city, and then one or more centers will be randomly selected from each region according to the number of centers covered in that region. And the list of health service centers in Gonabad will be prepared and in the following, sampling will be done in selected centers according to the population of women giving birth under the cover of that center. In order to randomly assign the samples to each of the 2 intervention and control groups, 2.4 variable blocks are used. In this way, first 7 possible states of blocks (BBAA, BABA, ABBA, BAAB, AB, AABB, ABAB) are listed and numbers 1 to 7 are assigned to each block. Then, a number between 1 and 7 is randomly selected and then people are assigned to the group receiving additional folic acid supplement (B) and the control group (A) based on the block corresponding to the selected number. This work continues until the sample volume is completed, Blinding description: Monetization will be (available) in a non-random way. In order to randomly assign the samples to each of the 2 intervention and control groups, 2-4 variable blocks are used. In this way, first, 7 possible states of blocks (BBAA, BABA, ABBA, BAAB, AB, AABB, ABAB) are listed and numbers 1 to 7 are assigned to each block. Then, a number between 1 and 7 is randomly selected, and then people are assigned to the folic acid supplement group (B) and the control group (A) based on the block corresponding to the selected number. This work continues until the sample volume is completed. 3 Postpartum depression. Intervention 1: Intervention group: 500 mg of folic acid tablets daily (take half of a tablet of 1 mg of folic acid), will be given for 8 weeks. Intervention 2: Control group: And mothers of the control group will be advised to use a placebo daily for 8 weeks. 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 I haven't made a decision yet
public Mahnaz Mohammadizadeh
No. 8, 27 Imam Khomeini Plantains, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9361765834 +98 51 4612 0388 mh.mohamdizadeh@gmail.com Gonabad University of Medical Sciences scientific mahnaz mohammadizadeh sarab
, Razavi, Khorasan27 Imam Khomeini PlanarNo. 8,
mashhad Iran (Islamic Republic of) 93617-65834 +98 51 4612 0388 mh.mohamdizadeh@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Pregnancy without disease (nervous problems, bipolar, depression, anxiety, epilepsy, lack of anencephaly or neural tube defects underlying diseases including: diabetes, blood pressure - hypothyroidism - hyperthyroidism) according to the mother's statement or health record Women on day 3-5 after giving birth Having a live baby Age 54-10 years People who have a normal body mass index in the first 12 weeks of pregnancy (18/24/5) and overweight during pregnancy in the normal range (11/5/16) Depression score less than 12 A singleton pregnancy Informed consent has been obtained Regular consumption of pregnancy supplements according to the instructions of the Ministry of Interior (from the 16th week to the end of pregnancy) 10 years 54 years Female Use of drugs other than post-natal supplements according to the statement of the patient or the doctor of the center Smoking or smoking F32.8 Other depressive episodes Prevention Placebo Intervention group: 500 mg of folic acid tablets daily (take half of a tablet of 1 mg of folic acid), will be given for 8 weeks. Control group: And mothers of the control group will be advised to use a placebo daily for 8 weeks. Depression score. Timepoint: Before the intervention, 1 and 2 months after start of the intervention. Method of measurement: Edinburgh depression questionnaire. Personal Approved 2023-12-25 Ethics Committee of Gonabad University of Medical Sciences Khorasan Razavi-Chanaran-Imam Khomeini 27, No. 8 Mashhad Razavi Khorasan Iran (Islamic Republic of)