A clinical trial with a control group, randomized with a random number table, on 68 primiparous women.
Settings and conduct
This clinical trial will be performed on 68 eligible women referred to Shahid Sadoughi Hospital in Yazd, who were in the first day after delivery, and after completing the single consent form, they will be randomly placed in the intervention or control group using a random number table. Grape juice is obtained from the Khorramasia Rahavaran factory, which produces grape molasses industrially and is licensed by the Ministry of Health. The intervention group will be prescribed 15 grams of oral grape molasses twice a day, from the first day after delivery to 30 days after delivery, but the control group will not be prescribed grape molasses . 1 and 3 months after delivery, people in both groups will be contacted to fill out the Edinburgh Questionnaire by telephone. Both groups will be assessed for their average Edinburgh score and the incidence of depression.
Participants/Inclusion and exclusion criteria
Entry conditions:
First pregnancy experience
Exclusion criterion:
Allergy to grape molasses
Taking antidepressants, anti-anxiety and anti-stress drugs
Having gestational diabetes or other diabetes
Having a contraindication to carbohydrates
Intervention groups
This clinical trial will be performed on primiparous women. The intervention group will receive 15 grams of grape molasses twice a day from the first day after delivery until 30 days later. But the control group will not receive grape molasses.
Main outcome variables
The Postpartum Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140817018828N8
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Alimohammad Ranjbar
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
amranjbar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-17, 1400/01/28
Expected recruitment end date
2021-10-20, 1400/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the incidence of postpartum depression in "primiparous women receiving grape juice" and the control group
Public title
Evaluation of grape- molasses on prevention of postpartum depressive in primiparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy experience
Having Iranian nationality
Score less than 13 on the Edinburgh Questionnaire
women between the age of 20 – 35 years
Exclusion criteria:
Allergy to grape molasses
unwanted pregnancy
Taking antidepressants, anti-anxiety and anti-stress drugs
Having gestational diabetes or other diabetes
Having preeclampsia during pregnancy
Alcohol or drug use by the mother
Having medical disorders such as severe vomiting and nausea
Having a known systemic and chronic disease
History of infertility
Having drug allergies
Having a contraindication to carbohydrates
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
random number table:
Each person is assigned a 2-digit code from 01 to 68, respectively. Using a random table of numbers, "34 two-digit numbers less than 69" are selected, and each person whose code is between these 34 numbers is given grape molasses.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Boulevard of Shohadaye gomnam
City
YAZD
Province
Yazd
Postal code
00
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.292
Health conditions studied
1
Description of health condition studied
Postpartum Depression
ICD-10 code
F-53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Postpartum Depression Score in the Edinburgh Questionnaire
Timepoint
The first day, 1 and 3 months after delivery
Method of measurement
Edinburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receiving routine postpartum care, this group eats 15 grams of grape molasses by 15 cc modules twice daily (morning and evening) from the first day after delivery to 30 days after delivery (for 30 days). grape molasses is prepared from Khorramsahia factory, which is produced industrially.
Category
Prevention
2
Description
Control group: This group will receive only routine postpartum care and will not receive grape molasses from the first day after delivery until 30 days later.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital of Yazd
Full name of responsible person
Sedigheh Kardan
Street address
Ibn Sina Street
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 9007
Email
kardan.sedigheh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3724 0171
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alimohammad Ranjbar jamalabadi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
00
Phone
+98 35 1820 3419
Fax
+98 35 3820 3418
Email
amranjbar@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alimohamad Ranjbar Jamal abadi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
00
Phone
+98 35 1820 3419
Fax
Email
amranjbar@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sedigheh Kardan
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Boulevard of Shohadaye gomnam
City
Yazd
Province
Yazd
Postal code
00
Phone
+98 35 3820 5377
Email
kardan.sedigheh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available