Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Incidence of preterm preeclampsia
研究概览
简要总结
Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.
详细描述
This study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm PE is not inferior to 36 weeks of gestation. We will include pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors. During 12-16 weeks of gestation, the mean arterial pressure (MAP) and placental growth factor (PlGF) are measured, then initiating aspirin 100mg qn. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sFlt-1 and PlGF were detected at the same time. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. The incidence of preterm PE in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At <16 weeks of gestation, normal NT scan
- •At least 1 high risk factor or at least 2 moderate risk factors
- •Intend to receive prenatal examination and deliver in this institution
- •Signed a written informed consent for participation in the study
排除标准
- •Aspirin initiated after 16 week
- •Intolerant or allergic to aspirin
- •Aspirin adherence was <80%
- •Miscarriage or termination of pregnancy before randomization
- •drop out (do not return to the hospital for delivery).
- •Lost to follow-up
研究组 & 干预措施
Aspirin discontinuation group
initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, discontinuing aspirin at 28 weeks of gestation.
干预措施: aspirin discontinuation (Drug)
Control group
initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, continuing aspirin until 36 weeks of gestation.
干预措施: aspirin continuation (Drug)
结局指标
主要结局
Incidence of preterm preeclampsia
时间窗: Within one week after delivery
delivery with preeclampsia before 37 weeks of gestation
次要结局
- Incidence of small for gestational age(Within one week after delivery)
- Incidence of early-onset preeclampsia(Within one week after delivery)
- Incidence of term preeclampsia(Within one week after delivery)
- Incidence of gestational hypertension(Within one week after delivery)
研究者
FANG HE
Chief Physician/Professor of the Obstetrics Department
The Third Affiliated Hospital of Guangzhou Medical University