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

Preterm Birth Clinical Trial

— FOTIP  

Official title:

Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229526
• Other study ID #: DT2006-41-6257
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: August 29, 2014
• Start date: January 1990
• Est. completion date: December 1999

Study information

• Verified date: August 2014
• Source: Centre for Fetal Programming, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1619
• Est. completion date: December 1999
• Est. primary completion date: January 1996
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Hypertension, Pregnancy-Induced
• Intrauterine Growth Retardation
• Pregnancy Complications
• Pregnancy Induced Hypertension
• Premature Birth
• Preterm Birth

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sjurdur Frodi Olsen	Rigshospitalet, Denmark

References & Publications (2)

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

Outcome

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.