Status:
COMPLETED
Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')
Lead Sponsor:
Sjurdur Frodi Olsen
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Preterm Birth
Intrauterine Growth Retardation
Eligibility:
FEMALE
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 1990
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1999
Estimated Enrollment :
1619 Patients enrolled
Trial Details
Trial ID
NCT02229526
Start Date
January 1 1990
End Date
December 1 1999
Last Update
September 1 2014
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