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The effect of fish-oil supplementation on pregnancy outcomes in mother and infant

The effect of fish-oil supplementation on pregnancy outcomes in mother and infant: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013100914957N1
Enrollment
150
Registered
2014-02-14
Start date
2014-02-15
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Pregnancy, childbirth and the puerperium. Condition 2: Pregnancy, childbirth and the puerperium. Condition 3: Pregnancy, childbirth and the puerperium. Condition 4: Pregnancy, childbirth and the puerperium. Condition 5: Pregnancy, childbirth and the puerperium. Condition 6: Pregnancy, childbirth and the puerperium. Condition 7: Certain conditions originating in the perinatal period. Condition 8: Certain conditions originating in the perinatal period. Gestational [pregnancy-induced]

Interventions

Intervention 1: 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 (approxim
Treatment - Drugs
Placebo
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 e
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 (appro

Sponsors

National Public-Health Management Center (NPMC)
Lead Sponsor
Faculty of Nursing and Midwifery
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Postpartum Depression. Timepoint: 6-8 weeks after childbirth. Method of measurement: Edinburgh Depression Scale.;Newborn Weight. Timepoint: Childbirth. Method of measurement: By means of newborns scale into gram.;Infant Neurodevelopment. Timepoint: 4 and 6 month. Method of measurement: ASQ Questionnare.

Secondary

MeasureTime frame
Height and head circumference at birth. Timepoint: Postpartum. Method of measurement: Centimeter.;Low birth weight. Timepoint: postpartum. Method of measurement: by means of newborns scale into gram.;Depression in pregnancy. Timepoint: 16-20; 26-28; 35-37 weeks of pregnancy. Method of measurement: Edinburgh depression questionnare.;Preterm labor. Timepoint: childbirth. Method of measurement: weeks of pregnancy.;Preeclampsia. Timepoint: after 20th week of pregnancy until childbirth. Method of measurement: by use of measuring blood pressure and proteinuria.;Result of One-step, 2-h 75-g OGTT. Timepoint: 26-28 weeks. Method of measurement: glucose oxidase.;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.;Maternal weight gain. Timepoint: befor childbirth. Method of measurement: kilogram.;Lenght of pregnancy. Timepoint: delivery. Method of measurement: pregnancy duration from the first day of last menstrual period to childbirth; early sonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzizeh Farshbaf-Khalili

Research Center of NPMC/ Faculty of Nursing and Midwifery-Tabiz University of Medical Science

azizeh_farshbafkhalili@yahoo.com; farshbafa@tbzmed.ac.ir+98 41 1479 6770

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026