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

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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

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.

Condition or disease
Preeclampsia

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.

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Study Type : Observational
Actual Enrollment : 192 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
Actual Study Start Date : March 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357667


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Lisa Levine, MD UENN

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Responsible Party: Lisa Levine, Clinical Instructor, Department of Obstetrics & Gynecology Division of Maternal Fetal Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02357667     History of Changes
Other Study ID Numbers: 821592
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications