Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,619
- 主要终点
- Intrauterine growth retardation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Intrauterine growth retardation
时间窗: 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).
Pregnancy Induced Hypertension
时间窗: 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
Preterm delivery
时间窗: 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)
次要结局
未报告次要终点
研究者
Sjurdur Frodi Olsen
Chief Physician, Centre-Leader
Centre for Fetal Programming, Denmark