Clinical trial NCT02357667: The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
Official title: The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will take place on the obstetrical unit at the Hospital of the University of Pennsylvania (HUP) as well as in the outpatient setting. The patient population is primary from the surrounding urban region. The majority receive prenatal care at our institution. Based on fiscal year 2010 at HUP, the mean age was 24 years old and 85% were African American.

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.

Eligibility 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.

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.

Primary outcomes:
measure: Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)
timeFrame: 2 years
measure: Angiogenic factors and biomarkers of congestive heart failure (sFlt1)
timeFrame: 2 years
Secondary outcomes:
measure: Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)
timeFrame: 2 years
measure: Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)
timeFrame: 2 years
measure: Postpartum readmission rate
timeFrame: 2 years
measure: Pulmonary edema during labor and delivery or postpartum
timeFrame: 2 years
measure: Peripartum cardiomyopathy
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: UENN
name: Lisa Levine, MD
role: PRINCIPAL_INVESTIGATOR
References: