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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02229526 |
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Date of registration:
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03/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')
FOTIP |
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Scientific title:
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Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies |
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Date of first enrolment:
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January 1990 |
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Target sample size:
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1619 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02229526 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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Phase:
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N/A
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Contacts
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Name:
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Sjurdur F Olsen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Fetal Programming, Denmark |
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Name:
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Niels J Secher, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion 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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Intrauterine Growth Retardation
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Pregnancy Induced Hypertension
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Preterm Birth
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Intervention(s)
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Dietary Supplement: Low dose olive oil
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Dietary Supplement: High dose fish oil
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Dietary Supplement: High dose olive oil
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Dietary Supplement: Low dose fish oil
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Primary Outcome(s)
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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.]
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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.]
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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.]
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Secondary ID(s)
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DT2006-41-6257
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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