NCT03961360已完成2 期
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial)
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年5月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis
研究概览
简要总结
To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
162 mg/day Aspirin
Experimental
干预措施: Aspirin 162 mg (Drug)
81 mg/day Aspirin
Active Comparator
干预措施: Aspirin 81 mg (Drug)
结局指标
主要结局
Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis
时间窗: 3-7 months
based on American College Obstetrics and Gynecology (ACOG) guidelines
次要结局
- Neonatal Outcomes-Delivery at < 37 Weeks(at delivery)
- Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features(less than 37 weeks gestational age (GA))
- Maternal Outcomes-Number of Participants With Gestational Hypertension(3-7 months)
- Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia(from birth until discharge from NICU (about 1 to 4 weeks))
- Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis(from birth until discharge from NICU (about 1 to 4 weeks))
- Maternal Outcomes- Number of Participants With Postpartum Hemorrhage(1-24 hrs post delivery)
- Maternal Outcomes- Number of Participants With Other Maternal Bleeding(during labor to 24 hrs post delivery)
- Maternal Outcomes- Number of Participants That Required Blood Transfusion(during delivery)
- Maternal Outcomes- Number of Participants With Placenta Abruption(1 day)
- Maternal Outcomes- Number of Participants With Eclampsia(20 weeks)
- Maternal Outcomes- Number of Participants With HELLP Syndrome(4 weeks)
- Neonatal Outcome- Gestational Age at Delivery(at delivery)
- Neonatal Outcome-Small for Gestational Age(at delivery)
- Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay(from birth until discharge from NICU (about 1 to 4 weeks))
- Neonatal Outcomes-Apgar Score < 5 at 5 Minutes(5 minutes post delivery)
- Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV(from birth until discharge from NICU (about 1 to 4 weeks))
研究者
Farah Hassan Amro
Clinical Fellow OBGYN
The University of Texas Health Science Center, Houston
研究点 (1)
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