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

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ClinicalTrials.gov Identifier: NCT02229526
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Sjurdur Frodi Olsen, Centre for Fetal Programming, Denmark

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 1990
Actual Primary Completion Date : January 1996
Actual Study Completion Date : December 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Pregnancy Induced Hypertension [ 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. ]
    One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest

  2. Intrauterine growth retardation [ 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. ]
    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).

  3. Preterm delivery [ 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. ]
    Delivery at an estimated gestational age of less than 259 days (37 completed weeks)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229526


Sponsors and Collaborators
Sjurdur Frodi Olsen
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Niels J Secher, Professor Rigshospitalet, Denmark
Principal Investigator: Sjurdur F Olsen, Professor Center for Fetal Programming, Denmark

Publications of Results:
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Responsible Party: Sjurdur Frodi Olsen, Chief Physician, Centre-Leader, Centre for Fetal Programming, Denmark
ClinicalTrials.gov Identifier: NCT02229526     History of Changes
Other Study ID Numbers: DT2006-41-6257
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by Sjurdur Frodi Olsen, Centre for Fetal Programming, Denmark:
Fish oil supplementation
RCT
High risk pregnancies
Twin pregnancy
Preterm birth
Intrauterine growth retardation
Pregnancy induced hypertension
Additional relevant MeSH terms:
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Premature Birth
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes