Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-04-25 @ 2:00 AM
Study NCT ID:
NCT02935556
Status:
TERMINATED
Last Update Posted:
2024-03-20
First Post:
2016-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization and Epigenetics of Post-Partum Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA will be isolated from the whole blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low Accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'methylation signature on circulating monocytes', 'timeFrame': '1 week post delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post Partum Pre-eclampsia'], 'conditions': ['Post Partum Pre-eclampsia']}, 'descriptionModule': {'briefSummary': 'This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.', 'detailedDescription': 'Preeclampsia (PEC) is a heterogeneous disease that complicates 5-8% of pregnancies. Approximately 10% of PEC patients will present with post-partum PEC without having developed the syndrome during the pregnancy (PP-PEC). Management of post-partum preeclampsia (PP-PEC) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. The pathogenesis and clinical characteristics of PP-PEC are understudied and poorly understood. Identifying clinical risk factors and biomarkers of PP-PEC would help to identify women at risk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who present to the hospital with postpartum pre-eclampsia are matched with women who never have PP-PEC (post-partum preeclampsia).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post partum pre-eclampsia\n\nMatching based on:\n\n* maternal age (years +/-3)\n* BMI (+/-5 points)\n* Ethnicity\n* Mode of delivery\n* Gestational age at delivery (+/7 days)\n* Smoking status\n\nExclusion Criteria:\n\n* Intrapartum pre-eclampsia'}, 'identificationModule': {'nctId': 'NCT02935556', 'briefTitle': 'Characterization and Epigenetics of Post-Partum Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Characterization and Epigenetics of Post-Partum Preeclampsia', 'orgStudyIdInfo': {'id': 'PRO00104636'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'post partum pre-eclampsia', 'description': 'women with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery.', 'interventionNames': ['Other: no intervention']}, {'label': 'controls', 'description': 'women with normal deliveries and normal post part courses who match the post partum pre-eclampsia women in age, BMI, smoking status, gestational age and race/ethnicity.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'database and epigenetic study', 'armGroupLabels': ['controls', 'post partum pre-eclampsia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10023', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Marie-Louise Meng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York University', 'class': 'OTHER'}, {'name': 'Society for Obstetric Anesthesia and Perinatology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}