The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)
研究概览
简要总结
This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. The investigators will also look at associations of abnormal cardiovascular findings and immediate complications among a high risk cohort of pregnant African American women.
详细描述
This will be a prospective cohort study. Exposed cases will be admitted to the inpatient obstetrical unit (labor & delivery or antepartum unit) at the Hospital of the University of Pennsylvania with concern for severe preterm preeclampsia. Unexposed controls will be matched by gestational age and other clinical factors and will be obtained from the outpatient setting (Helen O Dickens clinic or Penn ObGyn Associates at 3701 Market Street). The investigators will compare cardiovascular risk factors between these two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included.
排除标准
- •Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded.
- •Unexposed controls:
- •Inclusion Criteria:
- •African American women obtaining prenatal care in our outpatient setting who meet matching criteria as noted above.
- •Exclusion Criteria:
- •Non-African American women and women who are not receiving care at our institution.
- •All women who do not speak English and who are unable to be consented will be excluded.
结局指标
主要结局
Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)
时间窗: 2 years
Angiogenic factors and biomarkers of congestive heart failure (sFlt1)
时间窗: 2 years
次要结局
- Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)(2 years)
- Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)(2 years)
- Postpartum readmission rate(2 years)
- Pulmonary edema during labor and delivery or postpartum(2 years)
- Peripartum cardiomyopathy(2 years)
研究者
Lisa Levine
Clinical Instructor, Department of Obstetrics & Gynecology Division of Maternal Fetal Medicine
University of Pennsylvania