This double-blind clinical trial study was conducted in 2012-2013 in Ahvaz health centers to determine the effects of Evening primrose oil on prevention, intensity and length of postpartum blues among 132 nulipara pregnant women (66 intervention and 66 control) aged between 18-35. Inclusion criteria involved mothers in their 36th week of gestational age and older while the exclusion criteria included mothers who had a history of systemic diseases, infertility, mental disorders, unwanted pregnancy or using similar supplements in the third trimester. Also, excluded from the study were those having abnormal pregnancy/birth or newborns with Apgar score less than 0.7, and those requiring hospitalization during the study. Subjects in the intervention group and the control group received Evening primrose oil and placebo respectively at the outset of the 37th week of pregnancy until two weeks after delivery. The samples were then evaluated on days 4, 10 and 14 postpartum and the data was analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052513452N1
Registration date:2015-10-02, 1394/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-02, 1394/07/10
Registrant information
Name
Soghra Nikoomazhab
Name of organization / entity
Ahvaz Jundishapour University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3552 3181
Email address
nikoomazhab.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2013-07-11, 1392/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Evening Primrose Oil on Postpartum Blue in Primiparus Women
Public title
The effect of Evening Primrose Oil on Postpartum Blue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 36 weeks or older;
Being the first and the only partner;
Exclusion criteria:
Requiring intervention to terminate pregnancy;
Giving birth to babies with Apgar score less than 0.7;
Requiring hospitalization of the newborn;
Having domestic problems;
Having history of infertility and/or systemic diseases;
Using similar supplements in the 3rd trimester;
Having unwanted pregnancy;
Getting a score above 23 in general health questionnaire;
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jondishapour University of Medical Sciences
Street address
Golestan Bulevard
City
Ahvaz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ETH505
Health conditions studied
1
Description of health condition studied
Postpartum Blue
ICD-10 code
0260.9
ICD-10 code description
Pregnancy-related condition, unspecified
Primary outcomes
1
Description
maternal blue
Timepoint
on days 4th, 10th and 14th postpartum
Method of measurement
edinburg scale
Secondary outcomes
1
Description
some sideffects like diarea or bloating
Timepoint
daily
Method of measurement
daily conection for taking history and clinical and physical examinatiom
Intervention groups
1
Description
Using 1 placebo softgel daily in control group
Category
Prevention
2
Description
using 1 gr evening primrose oil daily in intervention group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz East Health center
Full name of responsible person
Soghra Nikoomazhab
Street address
Behbehani bulvar
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice Chancellor for Research and Technology
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapour University 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
Ahvaz Jondishapour University Of Medical Sciences
Full name of responsible person
Soghra Nikoomazhab
Position
Master of Reproductive Health
Other areas of specialty/work
Street address
Ahvaz Jondishapour University Of Medical Sciences, Golestan Bulevard
City
Ahvaz
Postal code
Phone
+98 61 3336 7544
Fax
+98 61 3554 6092
Email
nikoomazhab.s@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University Of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Assistant Professor, PHD in Community Nutrition
Other areas of specialty/work
Street address
Ahvaz Jondishapour University Of Medical Sciences, Golestan bulevard
City
Ahvaz
Postal code
Phone
+98 61 3373 8331
Fax
Email
parvinabedi@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapour University Of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Assistant Professor, PhD in Community Nutrition
Other areas of specialty/work
Street address
Ahvaz Jondishapour University Of Medical Sciences, Golestan Bulevard
City
Ahvaz
Postal code
Phone
+98 61 3373 8331
Fax
Email
parvinabedi@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)