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"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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090801002266N19
Enrollment
105
Registered
2023-03-28
Start date
2023-05-22
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression. Puerperal psychosis

Interventions

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),
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 2
After delivery, 1 placebo tablet daily for one month.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholam Reza Kheirabadi

Esfahan University of Medical Sciences

kheirabadi@bsrc.mui.ac.ir+98 31 3668 0048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026