An interventional study of Low dose fish oil and Low dose olive oil in Preterm Birth, Intrauterine Growth Retardation and Pregnancy Induced Hypertension, sponsored by Sjurdur Frodi Olsen. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2014-09-01.
Sponsored by Sjurdur Frodi Olsen · Not applicable and Interventional
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.
2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 1,619 is above the median of 84 across 1,691 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with Sjurdur Frodi Olsen as lead sponsor.
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Exclusion Criteria:
Dietary Supplement: Low dose fish oil
Dietary Supplement: Low dose olive oil
Dietary Supplement: High dose fish oil
Dietary Supplement: High dose olive 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.
Also known as: Pikasol
Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
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.
Also known as: Pikasol
Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
Pregnancy Induced Hypertension
One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest
Time frame: 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).
Time frame: 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)
Time frame: 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.
No study locations are listed for this record.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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