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

Preeclampsia Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357667
• Other study ID #: 821592
• Status: Completed
• Start date: March 2015
• Est. completion date: April 20, 2017

Study information

• Verified date: May 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: April 20, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)		2 years
Primary	Angiogenic factors and biomarkers of congestive heart failure (sFlt1)		2 years
Secondary	Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)		2 years
Secondary	Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)		2 years
Secondary	Postpartum readmission rate		2 years
Secondary	Pulmonary edema during labor and delivery or postpartum		2 years
Secondary	Peripartum cardiomyopathy		2 years