The objective of this study is to investigate the effect of omega-3 fatty acids on pregnancy outcomes. 120 pregnant mothers (60 women in each intervention and control group) referred to the study clinics were assigned to receive salmon fish oil, 1000 mg capsules once daily since 16th gestational week until the end of pregnancy as well as routine prenatal care. The control group only received routine prenatal. Outcome measures were maternal weight gain and the average blood pressure at the end of pregnancy, pregnancy duration and time of PROM, gender, height, weight and head circumference of newborns.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811173291N1
Registration date:2010-06-03, 1389/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-03, 1389/03/13
Registrant information
Name
Masoumeh Davoodabadi Farahani
Name of organization / entity
School of Nursing and Midwifery, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3502
Email address
davoodabadi.m@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2006-09-30, 1385/07/08
Expected recruitment end date
2008-05-14, 1387/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical Trial on effect of omega-3 Fatty acids on pregnancy outcome
Public title
Pregnancy and Omega-3 supplements
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria: age 18 to 40 years, single pregnancy, the first visit before 16 weeks of pregnancy, weight before 16 weeks gestation 45 kg or more, and 4 or less parities .
Exclusion criteria: low or noncompliance, irregular visit, current gestational diabetes, fetal defects, delivery at home or outside the city of Arak
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Medical Sciences
Street address
Arak - St. Shiroodi - St. Alam al-Hoda - University of Medical Sciences
City
Arak
Postal code
Approval date
2006-08-07, 1385/05/16
Ethics committee reference number
85-15-1
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Neonate's Birth weight
Timepoint
at birth
Method of measurement
in grams
2
Description
Neonates height
Timepoint
at birth
Method of measurement
in centimeters
3
Description
Neonate's head circumference
Timepoint
at birth
Method of measurement
in centimeters
Secondary outcomes
empty
Intervention groups
1
Description
Fish oil (omega 3) Salmon, 1000 mg capsules, oral, once a day, since 16th gestational week until the end of pregnancy as well as routine prenatal care
Category
Other
2
Description
routine prenatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Aristotle Health center
Full name of responsible person
Street address
City
Arak
2
Recruitment center
Name of recruitment center
Aboureihan Health center
Full name of responsible person
Street address
City
Arak
3
Recruitment center
Name of recruitment center
Taleghani Health Center
Full name of responsible person
Street address
City
Arak
4
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Majid Ramezani
Street address
Arak University of Medical Sciences, Shiroodi St., Alam al-Hoda St., Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Davoodabadi Farahani
Position
Mentor faculty member / MSc Midwifery
Other areas of specialty/work
Street address
Midwifery group, Nursing and Midwifery college, Sardasht, Arak