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Clinical Trials/NCT02357667
NCT02357667
Completed
Not Applicable

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

University of Pennsylvania1 site in 1 country192 target enrollmentMarch 2015
ConditionsPreeclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia
Sponsor
University of Pennsylvania
Enrollment
192
Locations
1
Primary Endpoint
Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
April 20, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Levine

Clinical Instructor, Department of Obstetrics & Gynecology Division of Maternal Fetal Medicine

University of Pennsylvania

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)

Time Frame: 2 years

Angiogenic factors and biomarkers of congestive heart failure (sFlt1)

Time Frame: 2 years

Secondary Outcomes

  • 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)

Study Sites (1)

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