Clinical trial NCT02229526: Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')
Official title: Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Intrauterine Growth Retardation
Pregnancy Induced Hypertension
Keywords: Fish oil supplementation
RCT
High risk pregnancies
Twin pregnancy
Preterm birth
Intrauterine growth retardation
Pregnancy induced hypertension
Lead sponsor: Centre for Fetal Programming, Denmark
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2014-09-01
Enrollment: 1619
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Pregnancy Induced Hypertension
timeFrame: 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.
measure: Intrauterine growth retardation
timeFrame: 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.
measure: Preterm delivery
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Niels J Secher, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Fetal Programming, Denmark
name: Sjurdur F Olsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1471-0528.2000.tb13235.x.
citation: Olsen SF, Osterdal 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. doi: 10.1038/sj.ejcn.1602609. Epub 2007 Feb 7.