Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT02357667
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2015-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exposed cases:\n\nInclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.\n\nUnexposed controls:\n\nInclusion Criteria:\n\n* African American women obtaining prenatal care in our outpatient setting who meet matching criteria as noted above.\n\nExclusion Criteria:\n\n* Non-African American women and women who are not receiving care at our institution.\n\n * All women who do not speak English and who are unable to be consented will be excluded.'}, 'identificationModule': {'nctId': 'NCT02357667', 'acronym': 'SCOPE', 'briefTitle': 'The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study', 'orgStudyIdInfo': {'id': '821592'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed cases', 'description': 'African American women with concern for severe preterm (37 weeks gestation) preeclampsia who are admitted to the inpatient obstetrical unit at HUP.'}, {'label': 'Unexposed controls', 'description': 'African American women without preeclampsia or medical comorbidity who are matched by gestational age, maternal age, and BMI in the outpatient setting.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Lisa Levine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UENN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor, Department of Obstetrics & Gynecology Division of Maternal Fetal Medicine', 'investigatorFullName': 'Lisa Levine', 'investigatorAffiliation': 'University of Pennsylvania'}}}}