The Association Between Postpartum Aspirin Use and NT-proBNP Levels as a Marker for Maternal Health Outcomes.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- NT-proBNP Levels at 4-6 Weeks Postpartum
研究概览
简要总结
This study is a double-blinded randomized-controlled trial in which patients will be randomized to 81 mg of aspirin or placebo to be continued for 6 weeks' postpartum. The purpose of this study is to compare NT-proBNP levels at the 4-6 week postpartum visit between groups. There is currently no data on the maternal health effects associated with continuation of low-dose aspirin in the postpartum period. This study aims to fill a gap in the knowledge regarding the utility of low-dose aspirin following delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
1:1 fashion to aspirin 81 mg vs identical-appearing placebo to be continued for 6 weeks' postpartum. Patients will receive these medications prior to hospital discharge. Both the patient and provider will be blinded to their assigned group. NT-proBNP levels will be drawn at the 4-6-week postpartum visit. NT-proBNP levels will be compared between groups.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •English-speaking
- •postpartum
- •have met USPSTF recommendations for low-dose aspirin use during pregnancy: >1 high risk factor (history of preeclampsia in prior pregnancy, multifetal gestational, chronic hypertension, preexisting diabetes, renal disease, autoimmune disease) or >2 moderate risk factors (nulliparity, obesity, family history of preeclampsia, sociodemographic characteristics, age 35 years or older, or personal history factors) and reported at least 50% compliance with aspirin during pregnancy.
排除标准
- •hypersensitivity reaction to aspirin or other salicylates,
- •history of gastrointestinal bleeding
- •history of gastric or duodenal ulcers
- •severe hepatic dysfunction
- •bleeding disorders and diathesis
- •known cardiac dysfunction with reduced ejection fraction, or are taking or prescribed ACE inhibitors.
- •Patients who required ICU level care during their pregnancy will be excluded.
研究组 & 干预措施
Treatment Group
The treatment group will be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal.
干预措施: Aspirin 81Mg Ec Tab (Drug)
Placebo Group
The control group will receive a 6-week supply of placebo medication from the Investigational Pharmacy prior to discharge. The placebo will be identically appearing to the 81 mg aspirin. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal.
干预措施: Placebo (Drug)
结局指标
主要结局
NT-proBNP Levels at 4-6 Weeks Postpartum
时间窗: 4-6 weeks postpartum
The primary outcome for this analysis was NT-proBNP levels collected at the postpartum visit. Patients were reminded of this appointment the day prior to their scheduled follow-up visit. NT-proBNP levels were drawn at the 4-6 week postpartum visit. If patient did not present to their scheduled appointment, attempts were made to contact the patient and reschedule the visit and collect the lab sample for completion of the study.
次要结局
- Number of Participants With Preeclampsia Diagnosis Postpartum(6 weeks postpartum)
- Number of Participants With Eclampsia(4-6 weeks postpartum)
- Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications(6 weeks postpartum)
- Number of Participants Requiring Initiation or Increase in Blood Pressure Medications(4-6 weeks postpartum)
- Number of Participants With Hospital Readmission for Bleeding-related Complications(4-6 weeks postpartum)
- Number of Participants Needing Blood Transfusion(s)(4-6 weeks postpartum)