Effect of prescribed vitamin B6 for depression among “mothers at risk for postpartum depression” during the third trimester at selected health care centers Isfahan city 2016.
The aim of this study was to investigate the effect of prescribed vitamin B6 for depression among “mothers at risk for postpartum depression “during the third trimester at selected health care centers Isfahan city2016. This single blind clinical trial study was conducted via using placebo. The participants were selected at six health centers in Isfahan City. Pregnant women 18-45 years old, primi or multi porous, singleton at week 28 of pregnancy, without current prenatal depression. Including loss of sample size for each group was of 40 Pregnant women. Inclusion criteria: The criterion for entering this study was at least one risk factor of postpartum depression; physical health of pregnant mother; lack of current depression. Exclusion criteria: prenatal depression at third trimester; unwillingness to continue the study at any time .Simple random sampling, qualified inclusion in the study are placed in two groups, Case group and Control group. Case group {40 subjects receiving 2 tablets B6 ( 40mg,oral) daily from week 28 till end pregnancy; after delivery1 tablet B6 ( 40mg,oral) daily for one month and Control group {40subjects receiving placebo 2 tablets(oral) daily from week 28 till end pregnancy, after delivery receiving placebo 1 tablet(oral) daily for a month{received. Depression was evaluated via Edinburgh Standard questionnaire. Results in 2 stages, before intervention and 1.5 month after delivery will be evaluated. Questionnaires were completed by research’s units. The main outcome evaluated in this study changes Postpartum depression score in research’s units.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091929873N1
Registration date:2016-11-05, 1395/08/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-05, 1395/08/15
Registrant information
Name
Maryam Khodadad
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7532
Email address
mkhodadad@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-02-24, 1394/12/05
Expected recruitment end date
2016-04-08, 1395/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prescribed vitamin B6 for depression among “mothers at risk for postpartum depression” during the third trimester at selected health care centers Isfahan city 2016.
Public title
The effect of vitamin B6 in the prevention of postpartum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The criterion for entering this study was at least one risk factor of postpartum depression; physical health of pregnant mother; lack of current depression. Exclusion criteria: prenatal depression at third trimester; unwillingness to continue the study at any time
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street , Isfahan
City
Isfahan
Postal code
8199939438
Approval date
2016-02-24, 1394/12/05
Ethics committee reference number
IR.MUI.REC.1394.3.970
Health conditions studied
1
Description of health condition studied
postpartum depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
postpartum depression
Timepoint
The depression was evaluated baseline before intervention /and 1.5 month after delivery.
Method of measurement
Edinburgh standard questioner
Secondary outcomes
empty
Intervention groups
1
Description
Case group receive {2 tablets B6 (40mg; oral) daily; from week 28 till end pregnancy; after delivery1 tablet B6 (40mg; oral) daily for one month}. Every two weeks, Researcher phone calls to ensure, they were reminded of pills on phone and mentioned the subjects’ use of pill. Edinburgh postpartum depression questionnaires were completed by research’s units before intervention and 1.5 months after delivery.
Category
Placebo
2
Description
Control group receive { placebo 2 tablets oral ; daily from week 28 till end pregnancy, after delivery receiving placebo 1 tablet oral ; daily for a month} . The Placebo tablet has 6.2 mm in diameter and 100 mg weight and made from corn starch. The placebo tablet is Simulated of vitamin tablet B6 Amin pharmaceutical factory. Every two weeks, Researcher phone calls to ensure, they were reminded of pills on phone and mentioned the subjects’ use of pill. Edinburgh postpartum depression questionnaires were completed by research’s units before intervention and 1.5 months after delivery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
TheValieacr Haelth Center
Full name of responsible person
Dr Hamid Turk Zadeh
Street address
Parvin Street,Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
The Hazrate Ali Health center
Full name of responsible person
Dr Hamid Turk Zadeh
Street address
24 Metri Street , Isfahan
City
Isfahan
3
Recruitment center
Name of recruitment center
TheShahid Aval Health center
Full name of responsible person
Dr Hamid Turk Zadeh
Street address
Haftoon Street , Isfahan
City
Isfahan
4
Recruitment center
Name of recruitment center
The Shahid Motahari Health center
Full name of responsible person
Dr Hamid Turk Zadeh
Street address
Kaveh Street , Isfahan
City
Isfahan
5
Recruitment center
Name of recruitment center
The Ebne Sina Health center
Full name of responsible person
Dr Hamid Turk Zadeh
Street address
Ebne Sina Street , Isfahan
City
Isfahan
6
Recruitment center
Name of recruitment center
The Zeinabieh Health center
Full name of responsible person
Dr Hamid Turk Zadeh
Street address
Zeinabieh Street , Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Research Department of Medical Sciences
Full name of responsible person
Dr Mehdi Neematbakhsh
Street address
Isfahan University of Medical Sciences, Building Number 4 , Hezar Jerib Street, Isfahan
City
Isfahan
Grant name
جاری تحقیقات دانشگاه
Grant code / Reference number
1805003000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Research Department of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Maryam khodadad
Position
Master student midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar Jerib Street, Shiraz Gate, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 7532
Fax
+98 31 3669 9398
Email
mkhodadad@nm.mui.ac.irm418.khodadad@gmail.com
Web page address
nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Parvin Bahadoran
Position
Midwifery Department Nursing & Midwifery Faculty Isfahan
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar Jerib Street, Shiraz Gate, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 7532
Fax
+98 31 3669 9398
Email
bahadoran@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Kheirabadi
Position
Psychologist, Associate Professor of Psychiatry Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Noor Hospital , Ostandari Street , Isfahan , Iran.
City
Isfahan
Postal code
Phone
+98 31 3625 0111
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)