To assess the effect of saffron versus placebo on prevention of postpartum blues in primiparous women referring
Design
This is a double-blind randomized clinical trial, phase II, in which 100 eligible primiparous women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible primiparous women referring to the Comprehensive Health Centers in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age:18 to 35 years old; primiparous; singleton; term pregnancy; wanted pregnancy; the first marriage; normal delivery.
Exclusion criteria: mental disease; chronic diseases such as diabetes, hypertension, cardiovascular disease; history of infertility; hospitalization of the newborn in the intensive care unit.
Intervention groups
Intervention group:
routine postpartum care plus saffron capsule (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) daily for 14 days.
Control group: routine postpartum care plus placebo capsule (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) daily for 14 days.
Main outcome variables
Mean score of postpartum blues
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N336
Registration date:2020-01-27, 1398/11/07
Registration timing:prospective
Last update:2020-01-27, 1398/11/07
Update count:0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Saffron versus placebo on prevention of postpartum blues in primiparous women referring: a double-blind randomized clinical trial
Public title
Effect of Saffron versus placebo on prevention of postpartum blues in primiparous women referring
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years
Primiparous
Singleton
Term pregnancy
Wanted pregnancy
The first marriage
Normal delivery
Exclusion criteria:
Mental disease
Chronic diseases such as diabetes, hypertension, cardiovascular disease,
History of infertility
Hospitalization of the newborn in the intensive care unit
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelops. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.UMSHA.REC.1398.863
Health conditions studied
1
Description of health condition studied
Postpartum blues
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance
Primary outcomes
1
Description
Mean score of postpartum blues
Timepoint
Before the intervention and on 1, 5, 10 and 14 days after the intervention
Method of measurement
Using General Health Questionnaire (GHQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine postpartum care plus saffron capsule (manufactured by laboratory of School of Pharmacy, Hamadan University of Medical Sciences) daily for 14 days
Category
Treatment - Drugs
2
Description
Control group: Routine postpartum care plus placebo capsule (manufactured by laboratory of School of Pharmacy, Hamadan University of Medical Sciences) daily for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Mahtab Satari
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mahtabsattari212@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mahtab Satari
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mahtabsattari212@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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