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
Determining the effect of folic acid supplementation on postpartum depression in women referring to comprehensive health service centers in Mashhad and Gonabad in 1403-1402
Design
A clinical trial with a control group, a blind strain, randomized on 60 postpartum women
Settings and conduct
Astrology is available in Mashhad and Gonabad University of Medical Sciences and is performed in a randomized manner and is blinded and the study population is blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women on the 3rd-5th day after delivery, live baby, disease-free pregnancy, 10-54 years old, depression score less than 12, normal body mass index, regular use of pregnancy supplements, singleton pregnancy. Exclusion criteria: smoking or tobacco use, taking drugs other than supplements.
Intervention groups
Mothers in the intervention group were given 500 mg of folic acid tablets daily for 8 weeks. Mothers in the control group were given a placebo daily for 8 weeks.
Main outcome variables
Postpartum depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240107060642N1
Registration date:2024-01-30, 1402/11/10
Registration timing:registered_while_recruiting
Last update:2024-01-30, 1402/11/10
Update count:0
Registration date
2024-01-30, 1402/11/10
Registrant information
Name
Mahnaz Mohammadizadeh sarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4612 3001
Email address
mh.mohamdizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the effect of folic acid supplementation on postpartum depression in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
Use of drugs other than post-natal supplements according to the statement of the patient or the doctor of the center
Smoking or smoking
Age
From 10 years old to 54 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Khorasan Razavi-Chanaran-Imam Khomeini 27, No. 8
City
Mashhad
Province
Razavi Khorasan
Postal code
93617-65834
Approval date
2023-12-25, 1402/10/04
Ethics committee reference number
IR.GMU.REC.1402.133
Health conditions studied
1
Description of health condition studied
Postpartum depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
Primary outcomes
1
Description
depression score
Timepoint
Before the intervention, 1 and 2 months after start of the intervention
Method of measurement
Edinburgh depression questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
Control group: And mothers of the control group will be advised to use a placebo daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad and Gonabad comprehensive health service center