Objective: To determine the effect of fish oil supplementation on pregnancy outcomes in mother and infant: a randomized controlled clinical trial.
This is a randomized, triple blind, placebo-controlled multicenter study. 150 healthy pregnant women aged 18-35 years who are in 16-20 weeks of pregnancy will be recruited in the study. The study will be done at public health centers in Tabriz. The women will be allocated to the intervention and control groups using permuted block randomization with allocation ratio of 1:1. We will use sequentially numbered packs containing fish oil or placebo soft gels to conceal the allocation and maintain blinding. The capsules will be identical and unrecognizable for participants,and those involved in recruitment and data collection. Each fish oil soft gels will be 1000 mg containing 120 mg of DHA and 180 mg EPA. The soft gels will be taken once per day from end of the 20th week of pregnancy to 1 month after childbirth (approximately 24 weeks). Primary outcomes are the mean weight of newborns; postpartum depression; and infant neurodevelopment at the 4th and 6th months. At baseline and weeks 35-37, 3cc blood samples will be taken from the participants to examine the phospholipids.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100914957N1
Registration date:2014-02-14, 1392/11/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-02-14, 1392/11/25
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-15, 1392/11/26
Expected recruitment end date
2015-06-15, 1394/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fish-oil supplementation on pregnancy outcomes in mother and infant: a randomized controlled trial
Public title
The effect of fish-oil supplementation on pregnancy outcomes in mother and infant
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Healthy pregnant women in 16-20 weeks of pregnancy; Aged 18-35 years; 5th pregnancy or less; Singleton pregnancy; No history of infertility and premature birth; Not having history of depression or postpartum depression; Edinburgh depression score less than 23; Absence of known placenta previa or cerclage in this pregnancy; No adverse event occurred 6 months before the study
Exclusion criteria: Smoking or drugs using ;consumption of more than two servings fish per week; Having bleeding disorders or taking anticoagulants; BMI more than 30; participating in another study; Wanting to change living area in the next 6 months; No access to call phone; Being illiterate or unable to answer questions; History of sensitivity to fish oil or other fish products; sensitivity to gelatin; participation in other intervention study; Not willingness to participate; known underlying disease including heart, kidney, stomach, lung, thyroid or autoimmune diseases, diabetes, impaired glucose tolerance in pregnancy, epilepsy, essential hypertension,hyperlipidemia
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:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethical Committee for Medical Research
Street address
Research Deputy of Tabriz University of Medical Sciences, End of Gholgasht street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
92141
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O14
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria
2
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
3
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
060
ICD-10 code description
Preterm labour and delivery
4
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section
5
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium
6
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O26.9
ICD-10 code description
Pregnancy-related condition, unspecified
7
Description of health condition studied
Certain conditions originating in the perinatal period
ICD-10 code
P00.4
ICD-10 code description
Fetus and newborn affected by maternal nutritional disorders
8
Description of health condition studied
Certain conditions originating in the perinatal period
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
Postpartum Depression
Timepoint
6-8 weeks after childbirth
Method of measurement
Edinburgh Depression Scale
2
Description
Newborn Weight
Timepoint
Childbirth
Method of measurement
By means of newborns scale into gram
3
Description
Infant Neurodevelopment
Timepoint
4 and 6 month
Method of measurement
ASQ Questionnare
Secondary outcomes
1
Description
Height and head circumference at birth
Timepoint
Postpartum
Method of measurement
Centimeter
2
Description
Low birth weight
Timepoint
postpartum
Method of measurement
by means of newborns scale into gram
3
Description
Depression in pregnancy
Timepoint
16-20; 26-28; 35-37 weeks of pregnancy
Method of measurement
Edinburgh depression questionnare
4
Description
Preterm labor
Timepoint
childbirth
Method of measurement
weeks of pregnancy
5
Description
Preeclampsia
Timepoint
after 20th week of pregnancy until childbirth
Method of measurement
by use of measuring blood pressure and proteinuria
6
Description
Result of One-step, 2-h 75-g OGTT
Timepoint
26-28 weeks
Method of measurement
glucose oxidase
7
Description
Serum level of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
Timepoint
Befor intervention between 16-20 weeks; 35-37 weeks
Method of measurement
Gas chromatography
8
Description
Maternal weight gain
Timepoint
befor childbirth
Method of measurement
kilogram
9
Description
Lenght of pregnancy
Timepoint
delivery
Method of measurement
pregnancy duration from the first day of last menstrual period to childbirth; early sonography
Intervention groups
1
Description
Intervention: Fish oil soft gels (1000 mg contains 120 mg of DHA and 180 mg EPA) will be taken once per day from the end of 20th week of pregnancy to 1 month after childbirth (approximately 24 weeks equal to 168 capsules)
Category
Treatment - Drugs
2
Description
Control: Placebo soft gels identical with the fish oils soft gels regarding shape, size and weight, will be taken once per day from the end of 20th week of pregnancy to 1 month after childbirth (approximately 24 weeks equal to 168 capsules)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Public health centers of Tabriz
Full name of responsible person
Dr Mitra Yeghaneh
Street address
Tabriz Health Center
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Public-Health Management Center (NPMC)
Full name of responsible person
Mrs Jabbari
Street address
National Public-Health Management Center, Shahid Shafizadeh 24m Ave, Valiamr Square, Tavanir Outlet, Pasdaran Highway, Tabriz, Iran
City
ٰTabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Public-Health Management Center (NPMC)
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Miss Abbaszadeh
Street address
Faculty of Nursing and Midwifery, End of South-Shariati, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Nursing and Midwifery
Proportion provided by this source
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
Research Center of NPMC/ Faculty of Nursing and Midwifery-Tabiz University of Medical Science
Full name of responsible person
Azizeh Farshbaf-Khalili
Position
PhD Student of community Nutrition/ Midwifery educator
Other areas of specialty/work
Street address
Midwifery Department, Faculty of Nursing and Midwifery, End of South-Shariati Ave, Tabriz, Iran