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

Sjurdur Frodi Olsen

Status

Completed

Conditions

Pregnancy Induced Hypertension

Intrauterine Growth Retardation

Preterm Birth

Treatments

Dietary Supplement: High dose olive oil

Dietary Supplement: Low dose olive oil

Dietary Supplement: High dose fish oil

Dietary Supplement: Low dose fish oil

Study type

Interventional

Funder types

Other

Identifiers

NCT02229526

DT2006-41-6257

Details and patient eligibility

About

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.

Enrollment

1,619 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.