Determining the effect of fish oil supplementation on pregnancy outcomes in women with a history of high-risk pregnancies
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 in 200 patients,
Block randomization was used for randomization.
Settings and conduct
In this double-blind study, pregnant women referred to health centers with a history of high-risk pregnancies were divided into intervention and control groups using block randomization, and members of the intervention group from 16 weeks of gestation to the end of pregnancy, In addition to routine pregnancy care, they received a daily capsule of 1000 mg salmon oil containing essential fatty acids (fish oil and flax seed oil), and control group members received only routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 40 years
Second pregnancy and after that
History of problems such as preterm delivery; intrauterine growth retardation; preeclampsia; induced gestational hypertension in previous pregnancy
Exit criteria: Threat of miscarriage and placental previa in the current pregnancy
Intervention groups
From the 16th week of pregnancy, the intervention group was given one 1000 mg capsule of omega-3 fish oil daily until the end of the pregnancy, and routine pregnancy care was performed.
The control group received only routine pregnancy care.
Main outcome variables
Baby weight, Apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100701004281N3
Registration date:2020-07-13, 1399/04/23
Registration timing:retrospective
Last update:2020-07-13, 1399/04/23
Update count:0
Registration date
2020-07-13, 1399/04/23
Registrant information
Name
Azam Hamidzadeh
Name of organization / entity
Shahroud University of Medical Sceince
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
azhamidzadeh@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-03-30, 1394/01/10
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
2015-03-31, 1394/01/11
Actual recruitment end date
2016-02-15, 1394/11/26
Trial completion date
2016-02-15, 1394/11/26
Scientific title
Investigating the Effect of Fish Oil Supplement on Pregnancy Outcome in Women with a History of High-risk Pregnancy
Public title
Effect of Fish Oil Supplement on Pregnancy Outcome in Women with a History of High-risk Pregnancy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian race
Age between 18 and 40 years
Second pregnancy and after that
History of problems such as preterm delivery; intrauterine growth retardation; preeclampsia; induced gestational hypertension in previous pregnancy
The first visit to a medical center before the 16th week of pregnancy
Exclusion criteria:
Threat of miscarriage and placental abruption (bleeding) in the current pregnancy
Cervical cerclage
Having cardiovascular disease; kidney disease and lack of urinary tract infections; polyhydramnios; chronic lung disease; liver disease; hepatitis of any type; hyper and hypothyroidism; overt diabetes or gestational diabetes in previous pregnancies; diagnosis or suspicion of severe fetal abnormalities or hydrops in the current pregnancy
Substance abuse, alcohol and smoking; regular consumption of fish oil or nonsteroidal anti-inflammatory agents or other medications
Allergy to fish products
Lack of desire to take pill and irregular visit
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign patients to two groups of intervention and control, block randomization method with the size of four random blocks was used and randomization sequence was performed in the central committee.The sequence of randomization using web-based randomization is done through the following site:
https://www.Randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants were unaware of the study group they were in (intervention or control).
Also, the evaluation of the study results (pregnancy outcomes) was performed by a person outside the research team.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway, Yemen St., Shahid Arabi St., next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1983535511
Approval date
2015-09-06, 1394/06/15
Ethics committee reference number
IR.SBMU.RAM.REC.1394.201
Health conditions studied
1
Description of health condition studied
Increase of blood pressure during current pregnancy
ICD-10 code
O10
ICD-10 code description
Pre-existing hypertension complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Newborn Weight
Timepoint
At birth time
Method of measurement
By means of newborns scale into gram
2
Description
Apgar score in the first and fifth minutes
Timepoint
At birth time
Method of measurement
Observation and physical examination
Secondary outcomes
1
Description
Childbirth before 37 weeks
Timepoint
At the time of hospitalization
Method of measurement
Estimation of gestational age
2
Description
Increase of blood pressure
Timepoint
From the 16th week of pregnancy on prenatal visits
Method of measurement
By Blood pressure control device
3
Description
mode of delivery
Timepoint
at birth time
Method of measurement
observation
Intervention groups
1
Description
Intervention group: Soft capsule of 1000 mg salmon oil (Omega 3), without mercury, containing essential fatty acids (fish oil and flaxseed oil) made in Iran, Zahravi Pharmaceutical Company, each capsule of which contains 180 mg of eicosapentaenoic acid and 120 mg Ducosahexaenoic acid, and from the 16th week to the end of pregnancy, one capsule a day was given and it was recommended to be taken orally with food and water; Routine pregnancy care was also provided for this group
Category
Treatment - Drugs
2
Description
Control group: No intervention was performed and they only received routine pregnancy care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghalehmir health center
Full name of responsible person
Leila Khorasani
Street address
The main street of Ghalemir, next to the telecommunication
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 5686 6722
Email
kiani.m89@gmail.com
2
Recruitment center
Name of recruitment center
Salehabad health center
Full name of responsible person
Leila Khorasani
Street address
Next to Noor Al-Zahra school, end of the first 15 meters, Negarestan 18, Salehabad
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 4055 8917
Email
kiani.m89@gmail.com
3
Recruitment center
Name of recruitment center
Fesharghavi health center
Full name of responsible person
Leila Khorasani
Street address
After Fathipour alley, corner of the first 10 meters, Shahid Sattari 30-meter street
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 5638 2648
Email
kiani.m89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Kiani
Position
Faculty member of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahroud University of Medical Sciences, School of nursing and Midwifery, 7 Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
00
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
kiani.m89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Robabeh Taheripanah
Position
Faculty member of university
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Unit 10, Second Floor, Green Building, at the beginning of Zafar, Dr. Shariati St.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2222 3327
Fax
+98 21 2290 2958
Email
info@taheripanah.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Kiani
Position
Faculty member of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahroud University of Medical Sciences, School of nursing and Midwifery, 7 Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
00
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
kiani.m89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is not further information
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