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

NCT02357667 | Completed

• 1 other identifier: 821592
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (2)

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

  2 years

• Angiogenic factors and biomarkers of congestive heart failure (sFlt1)

  2 years

Secondary Outcomes (5)

• 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 Arms (2)

Exposed cases

African American women with concern for severe preterm (37 weeks gestation) preeclampsia who are admitted to the inpatient obstetrical unit at HUP.

Unexposed controls

African American women without preeclampsia or medical comorbidity who are matched by gestational age, maternal age, and BMI in the outpatient setting.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• African American women obtaining prenatal care in our outpatient setting who meet matching criteria as noted above.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Evaluation of angiogenic factors, markers of heart failure, and evaluation of extracellular RNAs will specifically be used for discovery. The investigators will not be evaluating DNA.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Lisa Levine, MD

  UENN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor, Department of Obstetrics & Gynecology Division of Maternal Fetal Medicine

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 6, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 20, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-05

Locations

US (1)