Preterm Birth Clinical Trial
— FOTIPOfficial title:
Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies
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.
Status | Completed |
Enrollment | 1619 |
Est. completion date | December 1999 |
Est. primary completion date | January 1996 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Sjurdur Frodi Olsen | Rigshospitalet, Denmark |
Olsen SF, Østerdal ML, Salvig JD, Weber T, Tabor A, Secher NJ. Duration of pregnancy in relation to fish oil supplementation and habitual fish intake: a randomised clinical trial with fish oil. Eur J Clin Nutr. 2007 Aug;61(8):976-85. Epub 2007 Feb 7. — View Citation
Olsen SF, Secher NJ, Tabor A, Weber T, Walker JJ, Gluud C. Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team. BJOG. 2000 Mar;107(3):382-95. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
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