The objective of this study was to assess the effects of Omega-3 supplementation on high risk pregnancy for preeclampsia in Qazvin. 100 high risk pregnant women for preeclampsia between 14-18 weeks of gestation were included. 50 women were randomly assigned to receive omega-3, 1000 mg daily, till the end of pregnancy and 50 received placebo. Then preeclampcia rate and pregnancy outcome were assessed in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706061113N1
Registration date:2010-03-27, 1389/01/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-27, 1389/01/07
Registrant information
Name
Fatemeh Ranjkesh
Name of organization / entity
Qazvin University Of Medical Scienes, Nursing & Midwifery school
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 9501
Email address
franjkesh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Qazvin University of Medical Sciences, Zahravi medicine company
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2009-04-21, 1388/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega3 supplementation in preeclampsia in pregnant women at risk in Qazvin
Public title
The effect of omega3 supplementation in preeclampsia in pregnant women at risk in Qazvin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women whose gestational age is between 14 to 18 weeks and are ready to cooperate, being high risk for preeclampsia (first gravidy, under the age of 20 and over 40, a history of preeclampsia during the previous gravidy or immediate member of family, BMI more than 29, history of twin fetuses);
Inclusion criteria: consumption of Aspirin, Calcium, anticoagulants, allergy to omega3 or fish, presence digestive diseases which need to treatment,
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Qazvin University of Medical Sciences, Deputy for research
Street address
Deputy for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qazvin
Postal code
Approval date
2007-09-21, 1386/06/30
Ethics committee reference number
28/20/2696
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
014
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria
Primary outcomes
1
Description
hypertention
Timepoint
Every 4 hours
Method of measurement
determination of BP by the auscullatory method
2
Description
Proteinuria
Timepoint
daily
Method of measurement
Urine Protein
Secondary outcomes
1
Description
level of liver enzymes
Timepoint
daily
Method of measurement
laboratory
2
Description
headache
Timepoint
Every 4 hours
Method of measurement
Asking from patients
3
Description
thrombocytopenia
Timepoint
daily
Method of measurement
laboratory
4
Description
abdominal pain
Timepoint
Every 4 hours
Method of measurement
Asking from pateints
5
Description
vision problems
Timepoint
Every 4 hours
Method of measurement
Asking from patients
Intervention groups
1
Description
Omega-3, 1gram for 24 weeks
Category
Treatment - Drugs
2
Description
Placebo for 24 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban Health centers of Qazvin
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences, Zahravi drug company
Full name of responsible person
Fatemeh Ranjkesh
Street address
p.o.box: 34197-59811, nursing and midwifery faculty , Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences, Zahravi drug company
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
nursing and midwifery school
Full name of responsible person
Fatemeh Ranjkesh
Position
Msc in Midwifery,
Other areas of specialty/work
Street address
p.o.box: 34197-59811, nursing and midwifery faculty, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 1377 4540
Fax
Email
franjkesh@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
nursing and midwifery school
Full name of responsible person
Fatemeh Ranjkesh
Position
Msc in Midwifery
Other areas of specialty/work
Street address
p.o.box: 34197-59811, nursing and midwifery faculty, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 1377 4540
Fax
+98 28 1377 4540
Email
franjkesh@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
nursing and midwifery school
Full name of responsible person
Fatemeh Ranjkesh
Position
Msc in Midwifery
Other areas of specialty/work
Street address
p.o.box: 34197-59811, nursing and midwifery faculty, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
Fax
Email
franjkesh@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)