The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study

Conditions
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Preeclampsia

Participation Criteria
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Eligibility Criteria
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Exposed cases: Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed cases<br>African American women with concern for severe preterm (37 weeks gestation) preeclampsia who are admitted to the inpatient obstetrical unit at HUP. | |
| Unexposed controls<br>African American women without preeclampsia or medical comorbidity who are matched by gestational age, maternal age, and BMI in the outpatient setting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E) |  | 2 years | 
| Angiogenic factors and biomarkers of congestive heart failure (sFlt1) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |