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

Not Applicable

Completed

• Conditions: Intrauterine Growth Retardation; Pregnancy Induced Hypertension; Preterm Birth
• Interventions: Dietary Supplement: Low dose olive oil; Dietary Supplement: High dose fish oil; Dietary Supplement: High dose olive oil; Dietary Supplement: Low dose fish oil

• Registration Number: NCT02229526
• Lead Sponsor: Sjurdur Frodi Olsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1990-01
• Primary Completion: 1996-01
• Study Completion: 1999-12
• Study First Submitted: 2014-03-03
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-29
• Last Update Submitted: 2014-08-29
• Study First Posted: 2014-09-01
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1619

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose olive oil	Low dose olive oil	-
High dose fish oil	High dose fish oil	-
High dose olive oil	High dose olive oil	-
Low dose fish oil	Low dose fish oil	-

Primary Outcome Measures

Name	Time	Method
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).
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
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)