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Trial record 1 of 3 for:    SCOPE and Levine
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The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study (SCOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02357667
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Lisa Levine, University of Pennsylvania

Tracking Information
First Submitted Date January 28, 2015
First Posted Date February 6, 2015
Last Update Posted Date May 2, 2018
Actual Study Start Date March 2015
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2015)
  • Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E) [ Time Frame: 2 years ]
  • Angiogenic factors and biomarkers of congestive heart failure (sFlt1) [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02357667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 2, 2015)
  • Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry) [ Time Frame: 2 years ]
  • Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc) [ Time Frame: 2 years ]
  • Postpartum readmission rate [ Time Frame: 2 years ]
  • Pulmonary edema during labor and delivery or postpartum [ Time Frame: 2 years ]
  • Peripartum cardiomyopathy [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
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.
Condition Preeclampsia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2018)
192
Original Estimated Enrollment
 (submitted: February 2, 2015)
80
Actual Study Completion Date April 20, 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02357667
Other Study ID Numbers 821592
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lisa Levine, University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Lisa Levine, MD UENN
PRS Account University of Pennsylvania
Verification Date May 2018