Early Initiation of Low-Dose Aspirin for the Prevention of Preeclampsia 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
- 87
- 试验地点
- 1
- 主要终点
- preeclampsia occurance
研究概览
简要总结
Preeclampsia and its related consequences significantly contribute to maternal and neonatal morbidity and mortality, particularly in high-risk pregnancies. Low-dose aspirin has shown promise in reducing these risks, particularly when initiated early in gestation. This study evaluated the effectiveness of 75 mg aspirin, started before 12 weeks of gestation, in reducing adverse pregnancy outcomes among high-risk pregnant women.
A randomized controlled trial was undertaken with high-risk pregnant women. Pregnant women were randomized in a 1:1 ratio to receive 75 mg of aspirin or a control daily from enrollment (<12 weeks of gestation) until 36 weeks of delivery. High-risk status was defined by established clinical criteria. The incidence of preeclampsia was the primary outcome. The researchers considered preterm birth, fetal growth restriction (FGR), perinatal mortality, neonatal intensive care unit (NICU) admission, gestational hypertension, neonatal morbidity, and postpartum hemorrhage as secondary outcomes. The outcomes were compared using Fisher's exact test, chi-square, and two-sample z-tests.
Initiation of 75 mg of low-dose aspirin early in high-risk pregnancies significantly reduced preeclampsia and several adverse neonatal outcomes without increasing maternal risk. These findings support the early start of low-dose aspirin as a safe and effective strategy for preeclampsia prevention in high-risk women.
详细描述
Preeclampsia continues to be one of the most severe complications of pregnancy, substantially contributing to maternal and perinatal morbidity and mortality on a global scale. It is a multisystem hypertensive disorder that frequently presents with proteinuria or symptoms of maternal organ dysfunction and typically manifests after 20 weeks of gestation. Globally, preeclampsia affects between 3% and 8% of pregnant women, with higher rates reported in resource-limited settings. Its pathogenesis is complex and multifactorial, with growing evidence pointing toward abnormal placental development and impaired spiral artery remodeling during early gestation as initiating events. This aberrant placentation leads to uteroplacental ischemia, systemic endothelial dysfunction, oxidative stress, and an amplified inflammatory response, resulting in the clinical condition of preeclampsia.
This study aimed to assess the efficacy of low-dose aspirin (75 mg daily), commenced before 12 weeks of gestation, in decreasing the occurrence of preeclampsia. and other adverse pregnancy outcomes among women with clearly defined high-risk characteristics. In contrast to prior studies with broader inclusion criteria, this trial sought to isolate the impact of aspirin in a carefully selected cohort of women at elevated risk, utilizing a randomized controlled design. 13-15 Our secondary objectives included evaluating the effects of aspirin on fetal growth restriction, neonatal morbidity, perinatal death, preterm birth, and maternal complications such as postpartum hemorrhage and gestational hypertension.
This study is a randomized controlled trial conducted between [May 2023] and [May 2025]. The trial aimed to see if starting low-dose aspirin (75 mg) early can help reduce the chances of preeclampsia and related problems for mothers and babies in pregnant women who are at high risk. This study was approved by the Ethical Committee of the Faculty of Medicine, Beni-Suef University, with approval number REC/012/005752.
Inclusion Criteria
Pregnant women were considered according to the subsequent criteria:
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aspirin
Receiving low dose Aspirin
干预措施: Aspirin 75 mg (Drug)
结局指标
主要结局
preeclampsia occurance
时间窗: till end of pregnancy from week 12 to delivery
preeclampsia occurance in high risk pregnancy in both groups
次要结局
- Preterm birth(through study completion, an average of 1 year)
- Fetal growth restriction (FGR):(through study completion, an average of 1 year)
- Perinatal death:(at ≥20 weeks of gestation or neonatal death within 7 days of birth.)
- Neonatal intensive care unit admission (NICU).(delivery day)
- Composite neonatal morbidity(through study completion, an average of 1 year)
- Gestational hypertension(through study completion, an average of 1 year)
- Postpartum hemorrhage (PPH)(after delivery directly)
研究者
Eman Hamed
Lecturer of Clinical Pharmacy
Galala University