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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02357667

Acronym

SCOPE

Enrollment

192

Registered

2015-02-06

Start date

2015-03-31

Completion date

2017-04-20

Last updated

2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
Postpartum readmission rate	2 years
Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)	2 years
Peripartum cardiomyopathy	2 years
Pulmonary edema during labor and delivery or postpartum	2 years
Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)	2 years

Countries

United States

Outcome results