Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,106
- 试验地点
- 17
- 主要终点
- Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
研究概览
简要总结
The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Nulliparous (no previous pregnancy ≥ 22 SA)
- •Singleton pregnancy
- •Gestational age ≤ 15 +6 weeks
- •Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm)
- •Maternal informed consent obtained
- •Affiliated to social security system
排除标准
- •Women considering voluntary pregnancy termination (≤ 14 weeks)
- •Pre-existing (maternal) indication for premature delivery before 37 weeks
- •Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile)
- •Women under anticoagulation
- •Allergy or hypersensitivity to Kardegic® or one of its constituents
- •Secondary hemostasis disorder responsible for bleeding or risk of bleeding
- •Peptic ulcer under evolution
- •Lupus or antiphospholipid syndrome
研究组 & 干预措施
Aspirin
Aspirin 160 mg per day
干预措施: Aspirin (Drug)
Placebo
Placebo 160 mg per day
干预措施: Placebo (Drug)
结局指标
主要结局
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
时间窗: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
次要结局
- Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks(women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks)
- Severe pre-eclampsia (ACOG criteria)(women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks)
- Pre-eclampsia (ACOG criteria)(women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks)
- Adverse effects of treatment(women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks)
- Small for gestational age at birth (≤5th percentile on customized growth curves)(women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks)
- Perinatal death (22 weeks of gestation to 7 days postnatal)(women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks)