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

Sponsor

Sjurdur Frodi Olsen (Other)

Overall Status

Completed

CT.gov ID

NCT02229526

Collaborator

Rigshospitalet, Denmark (Other)

1,619

Enrollment

Arms

119

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Intrauterine Growth Retardation Pregnancy Induced Hypertension	Dietary Supplement: Low dose fish oil Dietary Supplement: Low dose olive oil Dietary Supplement: High dose fish oil Dietary Supplement: High dose olive oil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1619 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Official Title:

Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

Study Start Date :

Jan 1, 1990

Actual Primary Completion Date :

Jan 1, 1996

Actual Study Completion Date :

Dec 1, 1999

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low dose fish oil	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
Placebo Comparator: Low dose olive oil	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.
Experimental: High dose fish oil	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
Placebo Comparator: High dose olive oil	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.

Outcome Measures

Primary Outcome Measures

Pregnancy Induced Hypertension [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
Intrauterine growth retardation [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).
Preterm delivery [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sjurdur Frodi Olsen
Rigshospitalet, Denmark

Investigators

Principal Investigator: Niels J Secher, Professor, Rigshospitalet, Denmark
Principal Investigator: Sjurdur F Olsen, Professor, Center for Fetal Programming, Denmark