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Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')

Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

NCT02229526•Sjurdur Frodi Olsen

Summary

The initial trial examined if fish oil supplementation during pregnancy could reduce the risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in pregnancies that were at increased risk of these complications. The study was designed as a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•The low dose (prophylactic) section enrolled women who after 16 weeks of gestation had been identified with an uncomplicated pregnancy, who in an earlier pregnancy had experienced preterm delivery (this was subgroup 1)
•Intrauterine growth retardation (subgroup 2) or pregnancy induced hypertension (subgroup 3)
•Women who had been identified with twin pregnancies (subgroup 4)
•The high dose ('therapeutic') section enrolled women with threatening pre-eclampsia (subgroup 5) or suspected intrauterine growth retardation in the current pregnancy (subgroup 6).

Exclusion Criteria

•Diabetes mellitus in or before pregnancy
•Diagnosed severe fetal malformation or hydrops in current pregnancy
•Suspicion in current pregnancy, or occurrence in an earlier pregnancy, of placental abruption
•Drug or alcohol abuse
•Regular intake of fish oil or of non-steroidal antiinflammatory agents or other drugs with an effect on thombocyte function or eicosanoid metabolism
•Allergy to fish products.

Key Dates

Start Date

January 1, 1990

Primary Completion Date

January 1, 1996

Completion Date

December 1, 1999

Last Updated

September 1, 2014

Enrollment

1,619

ACTUAL participants

Conditions

Preterm BirthIntrauterine Growth RetardationPregnancy Induced Hypertension

Interventions

Low dose fish oil

DIETARY_SUPPLEMENT

Low dose olive oil

DIETARY_SUPPLEMENT

High dose fish oil

DIETARY_SUPPLEMENT

High dose olive oil

DIETARY_SUPPLEMENT

Stress Phenotypes and Preterm Birth

NCT05229666

Preterm BirthInflammation+2 more

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RECRUITINGPHASE2

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

NCT05703425

Preterm Birth

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RECRUITING

Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')

Inclusion Criteria

Exclusion Criteria

Stress Phenotypes and Preterm Birth

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment