A Pragmatic Randomized Study Comparing 81 mg Aspirin Versus 162 mg Aspirin in the Prevention of Preeclampsia During Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Preeclampsia
研究概览
简要总结
According to U.S. Pharmacist® "low-dose aspirin refers to dosages between 81 mg and 325 mg taken every day to prevent heart attacks, strokes, and colon cancer." It has been found through research that low-dose aspirin also decreases the risk of preeclampsia. The American College of Obstetrics and Gynecologists (ACOG) recommends low-dose aspirin (81mg/day) for women at high risk of preeclampsia. However, some researchers report that a dose of aspirin < 100 mg/day does not seem to decrease the risk of preeclampsia. Another trial studying patients who are at a high risk for preterm preeclampsia, reported a reduction in the occurrence of preeclampsia among patients taking aspirin at a dose of 150 mg.
The purpose of this pragmatic randomized study is to compare the difference in the effectiveness of two doses of aspirin: 81 mg versus 162 mg in the prevention of preeclampsia in pregnant women who are at a moderate to high risk for developing preeclampsia.
详细描述
Rationale - The risk factors associated with preeclampsia (early-onset and late-onset, singleton deliveries) include the following maternal characteristics and clinical factors (Washington State, 2003-2008; ACOG 2018): age < 20 years, age >34 years, African-American race, marital status-single, first pregnancy, diabetes mellitus, chronic hypertension, infertility treatment, infant sex male, and congenital anomalies.
Low dose aspirin decreases the risk of preeclampsia. The 2018 ACOG Committee Opinion on "Low-dose aspirin use during pregnancy" recommends the use of 81mg/day of aspirin for patients with risk factors for preeclampsia. However, it has been reported that a dose of aspirin < 100 mg/day does not seem to decrease the risk of preeclampsia.
Rolnick et al., studying patients at high risk for preterm preeclampsia, reported a 63% relative risk reduction among patients taking aspirin at 150mg per day versus placebo. We anticipate a more conservative rate of 40% relative risk reduction, from 35% to 21%, for patients taking 162mg per day.
Study/Project Population - We will include pregnant women up to 28.0 weeks gestation coming to the Regional One Health Obstetric (OB) Clinic for prenatal care, who meet ACOG's definition of high or moderate risk of developing preeclampsia during their current pregnancy (Low risk subjects will not be included).
Those risk factors are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant females ages 14 to 50 years old
- •Up to 28.0 weeks gestation (may initially base on last menstrual period (LMP), but confirmed with ultrasound (US)
- •Be at high risk or moderate risk for developing preeclampsia as defined by the American College of Obstetrics and Gynecologists (ACOG-2018), the Society for Maternal-Fetal Medicine (SMFM-2018), and the United States Preventive Services Task Force (USPSTF-2017)
排除标准
- •Less than 14 years old or greater than 50 years old
- •Allergy or contraindication to taking aspirin (i.e. nasal polyps, asthma with aspirin-induced bronchoconstriction)
- •History of gastrointestinal bleeding
- •Active peptic ulcer disease
- •Other sources of active Gastrointestinal/Genitourinary bleeding
- •Physician or provider refusal
- •Patient refusal
- •History of bleeding or clotting disorder (i.e. Factor V, von Willebrand, hemophilia)
- •Severe renal failure (Glomerular Filtration Rate < 10 ml/min)
- •Taking aspirin prior to pregnancy
研究组 & 干预措施
Group 1 - ACOG recommended dose
oral dose: 81 mg aspirin daily; designated by odd number assignment [1-001, 1-003, 1-005, etc. to 899]
干预措施: Aspirin 81 mg Enteric Coated Tab - 1 tablet (Drug)
Group 2 - Comparison Dose
oral dose: 162 mg aspirin daily; designated by even number assignment [2-002, 2-004, 2-006, etc. to 900]
干预措施: Aspirin 81 mg Enteric Coated Tab - 2 tablets (Drug)
结局指标
主要结局
Preeclampsia
时间窗: approximately 30 weeks; from 12 weeks gestation until the day of delivery
Occurrence of preeclampsia: categorized as - none, preterm, or term
次要结局
未报告次要终点