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Completed

NCT Number: NCT02229526

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

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.

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Key information

Conditions

Preterm Birth Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Hypertension Hypertension, Pregnancy-Induced Intrauterine Growth Retardation Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Induced Hypertension Premature Birth Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • There were six subgroups with different 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.

Treatment and study plan

Low dose fish oil

Dietary Supplement

Four 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 2.7 g n-3 fatty acids per day.

Other names: Pikasol

Low dose olive oil

Dietary Supplement

Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.

High dose fish oil

Dietary Supplement

Nine 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 6.1 g n-3 fatty acids per day.

Other names: Pikasol

High dose olive oil

Dietary Supplement

Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.

Primary outcomes

  1. Pregnancy Induced Hypertension

    Time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.

    One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest

  2. Intrauterine growth retardation

    Time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.

    Birth weight below the 10th centile, as assessed from the infant's birth weight, gestational age and gender, on the basis of Danish standards (Br J Obstet Gynaecol 1986; 93: 128-134; and Acta Obstet Gynecol Scand 1985; 64: 65-70).

  3. Preterm delivery

    Time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.

    Delivery at an estimated gestational age of less than 259 days (37 completed weeks)

Sponsors and collaborators

Lead sponsor

Sjurdur Frodi Olsen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

Acronym: FOTIP

Important dates

Study start
1990
Primary completion
1996
Study completion
1999
First posted
Sep 1, 2014
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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