Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-01 @ 8:41 PM
Study NCT ID:
NCT04142268
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2019-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic Women After Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-26', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2019-10-26', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The differences in longitudinal change pattern of CAVI between preeclampsia and normal pregnant women.', 'timeFrame': 'The CAVI was measured at one day, six months and one year after delivery in both groups.', 'description': 'The CAVI was analyzed with generalized estimating equation (GEE) method to evaluate the different change pattern of CAVI between two groups.'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': 'one day, six months and one year after delivery', 'description': 'automated blood pressure, mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'one day, six months and one year after delivery', 'description': 'automated blood pressure, mmHg'}, {'measure': 'Body weight', 'timeFrame': 'one day, six months and one year after delivery', 'description': 'kilograms'}, {'measure': 'Waist/Hip ratio', 'timeFrame': 'one day, six months and one year after delivery', 'description': 'Waist circumference in centimeter, Hip circumference in centimeter, Waist/Hip Circumference Ratio is the ratio of waist circumference divided by hip circumference'}, {'measure': 'Lipid profiles (Total cholesterol, TG, LDL, HDL)', 'timeFrame': 'one day, six months and one year after delivery', 'description': 'mg/dL (milligrams per deciliter)'}, {'measure': 'AST(aspartate aminotransferase), ALT(alanine aminotransferase)', 'timeFrame': 'one day, six months and one year after delivery', 'description': 'IU/L (International Units Per Litre)'}, {'measure': 'Serum creatinine', 'timeFrame': 'one day, six months and one year after delivery', 'description': 'mg/dL (milligrams per deciliter)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preelampsia', 'Cardio-ankle vascular index (CAVI)', 'Aortic stiffness', 'Blood pressure', 'LDL-cholesterol'], 'conditions': ['Preeclampsia and Eclampsia', 'Stiffness, Aortic', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '33176736', 'type': 'DERIVED', 'citation': 'Kim S, Lim HJ, Kim JR, Oh KJ, Hong JS, Suh JW. Longitudinal change in arterial stiffness after delivery in women with preeclampsia and normotension: a prospective cohort study. BMC Pregnancy Childbirth. 2020 Nov 11;20(1):685. doi: 10.1186/s12884-020-03374-0.'}]}, 'descriptionModule': {'briefSummary': 'The investigator measured the arterial stiffness using cardio-ankle vascular index (CAVI) test in patient with preeclampsia and normal pregnant women to evaluate the longitudinal change of CAVI and their predictors.', 'detailedDescription': 'This study was a case control study and included 37 women with preeclampsia (PE group) and 36 normotensive women (control group) who gave birth to child at Seoul National University Bundang Hospital.\n\nCario-ankle vasuclar index (CAVI) was measured at one day, six months and one year after delivery in both group.\n\nThe investigator also checked the body weight, blood pressure, lipid profile, serum creatinine, aspartate transaminase (AST) and alanine transaminase (ALT) simultaneously with CAVI.\n\nThe relationship between the presence of preelampsia and longitudinal changes of CAVI, blood pressure and metabolic indices were evaluated using generalized estimating equation (GEE) method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study included 37 women with preeclampsia (PE group) and 36 normotensive women (control group) who gave birth to child at Seoul National University Bundang Hospital from March 2013 to May 2016.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Case group : Women who were diagnosed preeclampsia based on the criteria of the International Society for the Study of Hypertension in Pregnancy\n2. Control group : Normotensive women who gave birth to child at Seoul National University Bundang Hospital.\n\nExclusion Criteria:\n\n* Women who were hemodynamically compromised or had bleeding complication after delivery were excluded.'}, 'identificationModule': {'nctId': 'NCT04142268', 'briefTitle': 'Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic Women After Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic and Normotensive Women After Delivery: One-Year Follow-Up Results', 'orgStudyIdInfo': {'id': 'B-1402-240-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preeclampsia group', 'description': 'PE was defined as diastolic BP of at least 110 mmHg on one occasion or diastolic BP of at least 90 mmHg on two consecutive occasions more than 4 hours apart, in combination with proteinuria (≥300 mg total protein in a 24-hour urine collection and, if this was not available, ≥+2 proteinuria by dipstick analysis on two consecutive occasions at least 4 hours apart) that develops after 20 weeks of gestation in previously normotensive women'}, {'label': 'Control group', 'description': 'Normal pregnancy group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jung-Won Suh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jung-Won Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}