Low Dose Aspirin for Prevention of Early Pregnancy Loss in Women at High Risk of Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Prevention of pregnancy loss
研究概览
简要总结
Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.
The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries
详细描述
The pathogenesis of preeclampsia (PE) is not fully understood, but it is believed to be associated with impaired early placental development, primarily attributed to defective trophoblast invasion and remodeling of the spiral arterioles .
Various mechanisms have been proposed to contribute to the development of preeclampsia, including angiogenesis, endothelial injury, oxidative stress, and inflammation, which lead to clinical manifestations such as hypertension, proteinuria, and end organ damage .
Preeclampsia is associated with severe short- and long-term maternal and neonatal morbidities, and its occurrence is influenced by risk factors such as diabetes, hypertension, multifetal gestation, as well as the severity and timing of previous preeclampsia episodes .
While low-dose aspirin (LDA) has shown some benefit in preventing preeclampsia and fetal growth restriction when initiated before 16 weeks' gestation, there is no widely effective prophylactic therapy, and delivery remains the primary approach to prevent maternal morbidity and mortality.
Recent research has indicated that LDA intervention, following firsttrimester screening of women at risk of developing preeclampsia, can significantly reduce the occurrence of preterm PE .
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Before 8 weeks gestation
- •Women at high risk of preeclampsia according to Royal College of Obstetricians and Gynecologists (RCOG) (Robson et al., 2013):
- •Maternal age ≥ 35 years.
- •Nulliparity.
- •BMI ≥ 30 kg/m
- •Smoking of r ≥ 10 cigarettes per day.
- •Previous history of small for gestational age (SGA) baby.
- •Previous history of stillbirth.
- •Pregnancy interval < 6 months or ≥ 60months.
- •Chronic hypertension.
- •Diabetes with vascular disease.
- •Willingness to participate in the study and provide informed written consent.
排除标准
- •Known allergy or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Use of any anticoagulant medication (e.g., heparin, warfarin, clopidogrel)
- •Use of low-dose aspirin for any indication prior to the current pregnancy
- •Chronic use of NSAIDs or corticosteroids
- •History of bleeding disorder or active bleeding
- •Any medical condition that may contraindicate the use of low-dose aspirin (e.g., peptic ulcer disease, asthma, liver, or kidney disease)
- •Multiple gestation
- •Inability to provide informed consent or comply with the study requirements.
研究组 & 干预措施
Group A (Experimental Group)
About 125 Participants in the treatment group will receive 81 mg low-dose aspirin once daily starting from the time of enrollment and continuing until the end of pregnancy
干预措施: Aspirin (Drug)
Group B (Control Group)
About 125 Participants will receive only the routine care of pregnancy until the end of pregnancy
干预措施: Aspirin (Drug)
结局指标
主要结局
Prevention of pregnancy loss
时间窗: From base line to the end of pregnancy
To investigate the efficacy of low dose aspirin (81 mg) for prevention of early pregnancy loss in women at high risk of preeclampsia.
次要结局
未报告次要终点