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Completed

NCT Number: NCT02357667

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 2 years

  2. Angiogenic factors and biomarkers of congestive heart failure (sFlt1)

    Time frame: 2 years

Secondary outcomes

  1. Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)

    Time frame: 2 years

  2. Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)

    Time frame: 2 years

  3. Postpartum readmission rate

    Time frame: 2 years

  4. Pulmonary edema during labor and delivery or postpartum

    Time frame: 2 years

  5. Peripartum cardiomyopathy

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: SCOPE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2015
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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