Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- Prevention of preeclampsia
研究概览
简要总结
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 13 and 16 weeks of pregnancy
- •High risk of preeclampsia, based in clinical risk factors as:
- •Preeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index > 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.
排除标准
- •Blood coagulation disorders of any kind
- •Peptic ulcers
- •Allergy to aspirin
- •Chronic use of anti-inflammatory drugs
- •Fetus with mayor anomalies
研究组 & 干预措施
Aspirin
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
干预措施: Aspirin (Drug)
Placebo
Placebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
干预措施: Placebo (Drug)
结局指标
主要结局
Prevention of preeclampsia
时间窗: 6 months
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy
次要结局
- Neonatal intensive care unit admissions.(28 days)
- Neonatal deaths(6 months)
- Prevention of preeclampsia at term(6 months)
- Stillbirth(6 months)
- Abruptio placenta(6 months)
- Fetal Growth Restriction(6 months)
研究者
Osvaldo A. Reyes T.
Coordinator of Research
Saint Thomas Hospital, Panama