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

Completed

• Conditions: Preeclampsia

• Registration Number: NCT02357667
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Study Start: 2015-03
• Primary Completion: 2017-04
• Study Completion: 2017-04-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Postpartum readmission rate	2 years
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
Pulmonary edema during labor and delivery or postpartum	2 years
Peripartum cardiomyopathy	2 years

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States