162 mg of Aspirin for Prevention of Preeclampsia
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of participants with eclampsia
研究概览
简要总结
This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.
详细描述
After screening to meet inclusion criteria, pregnant patients at the Family Medicine Clinic will be asked to take 162 mg aspirin daily for 6 months, starting at about 12 weeks gestation and continued until the end of pregnancy. They will be monitored every 4 weeks until week 28, then every 2 weeks until week 36, and then weekly from week 36 on. Participants will be screened at these visits for medication compliance (taking, missed doses, side effects, etc). Patients will be subject to lab work as is routinely indicated for preeclampsia.
At the end of the study period, accumulated study data will be compared with historical data from the Family Medicine Clinic on rates of preeclampsia and outcomes in patients taking 81 mg for preeclampsia prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any pregnant patient at Peoria FMC
- •Hx of pre-eclampsia
- •Multifetal gestation
- •Chronic hypertension
- •Type 1 or 2 diabetes
- •Autoimmune disease
- •Renal disease
- •Nulliparity
- •Family Hx of pre-eclampsia
- •Sociodemographic characteristics
- •Age >= 35 years of age
- •Personal history factors (LBW, SGA, > 10-year pregnancy interval, adverse pregnancy outcomes
排除标准
- •At high risk of side effects from ASA therapy
- •Hx of hemorrhagic stroke
- •Hx of GI bleed, G6PD
- •Liver disease
- •NSAID or Salicylate allergy)
- •Patients confirmed to be not compliant with therapy
研究组 & 干预措施
Intervention with 162 mg aspirin
Aspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic
干预措施: Aspirin 162 mg (Drug)
结局指标
主要结局
Number of participants with eclampsia
时间窗: Anytime during pregnancy and 3 months post partum
new onset of seizures in pregnant woman with preeclampsia
Number of participants with preeclampsia
时间窗: Through study completion, estimated 18 months
Dangerous pregnancy complication characterized by high blood pressure
次要结局
- Number of participants with post partum hemorrhage(Through study completion, estimated 18 months)
- Number of participants with placental abruption(Through study completion, estimated 18 months)
- Number of participants with aplastic anemia(Through study completion, estimated 18 months)
- Number of participants with agranulocytosis(Through study completion, estimated 18 months)
- Number of participants with anaphylaxis(Through study completion, estimated 18 months)
研究者
Paul M Goldsmith, DO
Resident Physician
Methodist Medical Center of Illinois