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

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

Conditions
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Preterm Birth, Intrauterine Growth Retardation, Pregnancy Induced Hypertension

Intervention / Treatment
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* Dietary Supplement: Low dose fish oil
* Dietary Supplement: Low dose olive oil
* Dietary Supplement: High dose fish oil
* Dietary Supplement: High dose olive oil


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose fish oil<br> | Dietary Supplement: Low dose fish oil<br>* 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.<br>* Other names: Pikasol;|
| Placebo Comparator: Low dose olive oil<br> | Dietary Supplement: Low dose olive oil<br>* Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.<br>|
| Experimental: High dose fish oil<br> | Dietary Supplement: High dose fish oil<br>* 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.<br>* Other names: Pikasol;|
| Placebo Comparator: High dose olive oil<br> | Dietary Supplement: High dose olive oil<br>* Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Induced Hypertension | One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest | 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. | 
| Intrauterine growth retardation | 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). | 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. | 
| Preterm delivery | Delivery at an estimated gestational age of less than 259 days (37 completed weeks) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish oil supplementation, RCT, High risk pregnancies, Twin pregnancy, Preterm birth, Intrauterine growth retardation, Pregnancy induced hypertension