A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 12
- 主要终点
- Delivery before than 37 weeks gestation
研究概览
简要总结
A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."
详细描述
Preterm birth is the leading cause of perinatal mortality and morbidity. In a recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P), the National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network found the treatments significantly beneficial in the prevention of recurrent preterm birth. Other studies have shown that fish oil supplementation can reduce the risk for preterm birth. The purpose of this study is to determine whether Omega-3, a polyunsaturated fatty acid nutritional supplement, in addition to injections of 17P, further decreases the rate of preterm birth in women at risk.
This study is a randomized, double-masked clinical trial with two study arms: a daily supplement of Omega-3 capsules containing 800 mg of DHA and 1200 mg of EPA or a daily supplement of a matching placebo. All patients will also receive weekly injections of 17P. Eight hundred pregnant women with a history of previous preterm delivery will be recruited for this study. After successfully completing a compliance run-in, which can begin as early as 15 weeks gestation, patients will be randomized and begin treatment between 16 and 22 weeks gestation. They will remain on study drug until 36 week and 6 days or delivery, whichever occurs first. Blood will be drawn at randomization and at a monthly visit falling between 25-29 weeks of gestation to test for compliance, to analyze genetic polymorphisms and to determine whether Omega-3 affects the production of inflammatory cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Documented history of previous singleton spontaneous birth
- •Singleton pregnancy
- •Gestational age at randomization between 16 and 22 weeks
排除标准
- •Major fetal anomaly or demise
- •Regular intake of fish oil supplements
- •Daily use of nonsteroidal anti-inflammatory agents
- •Allergy to fish or fish products
- •Gluten intolerant
- •Heparin use or known thrombophilia
- •Hemophilia
- •Planned termination
- •Current hypertension or current use of antihypertensive medications
- •Type D, F or R diabetes
- •Maternal medical complications
- •Current or planned cerclage
- •Illicit drug or alcohol abuse during current pregnancy
- •Delivery at a non-Network hospital
- •Participation in another pregnancy intervention study
- •Participation in this trial in a previous pregnancy
研究组 & 干预措施
17P plus Omega-3 Supplement
Weekly 17 alpa hydroxyprogesterone caproate (17p) injections plus Omega 3 supplements, 4 capsules per day for up to 5 weeks. Each capsule contained 200 mg of docosahexaenoic acid (DHA) and 300 mg of eicosapentaenoic acid (EPA).
干预措施: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement (Drug)
17P plus Placebo Supplement
Weekly 17 alpa hydroxyprogesterone caproate (17p) injections plus placebo capsules, 4 capsules per day for up to 5 weeks
干预措施: 17 alpha-hydroxy progesterone caproate and Placebo supplement (Drug)
结局指标
主要结局
Delivery before than 37 weeks gestation
时间窗: Up to 37 weeks gestation
Delivery before 37 weeks including any miscarriages occurring after randomization
次要结局
- Birth weight less than 2,500 grams(Birth)
- Birth weight less than 1,500 grams(Birth)
- Delivery before 35 weeks gestation(Up to 35 weeks gestation)
- Delivery before 32 weeks gestation(Up to 32 weeks gestation)
- Delivery after 40 weeks gestation(40 weeks gestation or greater)
- Pregnancy loss or neonatal death(Randomization to hospital discharge (up to 25 weeks))
- Gestational age at delivery(Delivery)
- Neonatal surfactant use(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal bronchopulmonary dysplasia(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal transient tacypnea(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal supplemental oxygen support(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal ventilator support(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal respiratory distress syndrome(Delivery through neonatal discharge (up to 2 weeks))
- Birth size small for gestational age at less than 10th percentile(Birth)
- Birth size large for gestational age at more than 90th percentile(Birth)
- Admission to neonatal intensive care or intermediate care nursery(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal retinopathy of prematurity(Delivery through neonatal discharge (up to 2 weeks))
- Intraventricular Hemorrhage at any grade(Delivery through neonatal discharge (up to 2 weeks))
- Intraventricular Hemorrhage Grade 3 or 4(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal patent ductus arteriosus(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal necrotizing enterocolitis(Delivery through neonatal discharge (up to 2 weeks))
- Neonatal sepsis(Delivery through neonatal discharge (up to 2 weeks))