Intrauterine Growth Retardation, Pregnancy Induced Hypertension, Preterm Birth
Conditions
Keywords
Fish oil supplementation, RCT, High risk pregnancies, Twin pregnancy, Preterm birth, Intrauterine growth retardation, Pregnancy induced hypertension
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.
Interventions
DIETARY_SUPPLEMENTLow 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.
DIETARY_SUPPLEMENTLow 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.
DIETARY_SUPPLEMENTHigh 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.
DIETARY_SUPPLEMENTHigh 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.
Sponsors
Rigshospitalet, Denmark
Sjurdur Frodi Olsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Induced Hypertension | 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. | One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest |
| Intrauterine growth retardation | 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. | 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). |
| Preterm delivery | 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. | Delivery at an estimated gestational age of less than 259 days (37 completed weeks) |
Outcome results
None listed