Trial | NCT02229526  Report issue

Title

Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')
Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    olive ...

  • Study Participants

    1619
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.
Study Started
Jan 31
1990
Primary Completion
Jan 31
1996
Study Completion
Dec 31
1999
Last Update
Sep 01
2014
Estimate

Dietary Supplement Low dose fish oil

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

Dietary Supplement Low dose olive oil

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

Dietary Supplement High dose fish oil

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

Dietary Supplement High dose olive oil

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

Low dose fish oil Active Comparator

Low dose olive oil Placebo Comparator

High dose fish oil Experimental

High dose olive oil Placebo Comparator

Criteria 

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.
No Results Posted