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IRCT20090801002266N19 IRCT 2023-03-28 Esfahan University of Medical Sciences "Effect of folic acid and vitamin B6"; "Prevention of postpartum depression" A Comparative Study of the Effects of Folic Acid and Vitamin B6 in the Prevention of Postpartum Depression in Mothers at Risk of Postpartum Depression 2023-05-22 anticipated 105 Complete https://irct.ir/trial/67300 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Prevention, Randomization description: People are selected by simple randomization and in the order of visiting health centers where the plan is implemented and if they agree. These people are placed in groups of three in blocks of three, and the people of each block are placed in one of the three intervention groups by simple random selection of envelopes containing numbers 1 to 3, Blinding description: The present study is a double-blind clinical trial study with placebo. Medicines and placebo are packed inside capsules of the same shape and color so that they cannot be distinguished for clients. 1-2 Postpartum Depression. Intervention 1: The first intervention group: 35 people receiving 2 tablets of B6 (Prepared from Amin Pharmaceutical Factory), 40 mg daily, from the 26th week of pregnancy until the end of pregnancy; After giving birth, 1 tablet of B6, 40 mg daily, for one month. Intervention 2: Intervention group: 35 people receiving 2 tablets of folic acid 1 mg daily (Prepared from Amin Pharmaceutical Factory), food from the 26th week of pregnancy until the end of pregnancy; After giving birth, 1 tablet of folic acid 1 mg per day for one month. Intervention 3: Control group: 35 people receiving 2 placebo tablets (Prepared from Amin Pharmaceutical Factory) daily from the 26th week of pregnancy until the end of pregnancy; After delivery, 1 placebo tablet daily for one month. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts one year after publication of the results To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: After the publication of the results in the form of an article and with full observance of the confidentiality of the data in such a way that the data related to each person cannot be identified individualy. Where to obtain: kheirabadi@bsrc.mui.ac.ir Gholam Reza Kheirabadi Professor of Psychiatry Department of Psychiatry, School of Medicine Behavioral Sciences Research Center Nour & Ali-Asghar Hospital Isfahan University of Medical Sciences How to obtain: Send an email to the project manager Comments:
public Gholam Reza Kheirabadi
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences scientific Gholam Reza Kheirabadi
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Pregnant women 18 to 45 years old Women should be in the third trimester of pregnancy. People have a previous history of depression or anxiety based on history. People have a positive family history of depression. 7 to 15 anxiety or depression score based on HADS screening questionnaire People have a low or very low social support score in the NSSQ social support questionnaire. 18 years 45 years Female Women who give birth under 37 weeks. Women who have a score below 7 and a score above 15 of anxiety or depression based on the HADS screening questionnaire. Lack of consent to participate in the study Women with treatment for depression or any type of psychiatric disorder Women under medical treatment due to high-risk pregnancy Women with limited mobility due to high-risk pregnancy Women with a history of receiving folic acid at a dose greater than 1 mg per day or a history of receiving B6 daily F53 Puerperal psychosis Treatment - Drugs Treatment - Drugs Placebo The first intervention group: 35 people receiving 2 tablets of B6 (Prepared from Amin Pharmaceutical Factory), 40 mg daily, from the 26th week of pregnancy until the end of pregnancy; After giving birth, 1 tablet of B6, 40 mg daily, for one month. Intervention group: 35 people receiving 2 tablets of folic acid 1 mg daily (Prepared from Amin Pharmaceutical Factory), food from the 26th week of pregnancy until the end of pregnancy; After giving birth, 1 tablet of folic acid 1 mg per day for one month. Control group: 35 people receiving 2 placebo tablets (Prepared from Amin Pharmaceutical Factory) daily from the 26th week of pregnancy until the end of pregnancy; After delivery, 1 placebo tablet daily for one month. Postpartum depression score based on the Edinburgh Postpartum Depression Scale. Timepoint: before the intervention and one and a half months after delivery. Method of measurement: In this research, it is measured by questionnaire and interview method. These questionnaires include 1- Demographic Characteristics Questionnaire 2- HADS 2 Questionnaire 3- Edinburgh Depression Questionnaire 4- Social Support Questionnaire (NSSQ). Esfahan University of Medical Sciences Approved 2022-11-27 Ethics committee of Isfahan University of Medical Sciences Hazar Jarib St., Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)