Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT00919360
Status:
TERMINATED
Last Update Posted:
2015-10-21
First Post:
2009-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression In Pregnancies Complicated by Preeclampsia
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_WITH_DNA', 'description': 'serum, placental and decidual tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'whyStopped': 'PI is no longer at University of Rochester, has moved to University of Florida, Gainesville. PI email now homonq@ufl.edu. Phone is 352-273-7675', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2009-06-10', 'studyFirstSubmitQcDate': '2009-06-10', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative pattern of expression in cases and matched controls of a robust set of genes in the VEGF/sFLT mediated model for preeclampsia in the placenta and decidua', 'timeFrame': '1- 2 years'}], 'secondaryOutcomes': [{'measure': 'From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.', 'timeFrame': '1- 2 years'}, {'measure': 'Using relative expression analysis in an embedded set of control subjects, determine whether common variables e.g. labor, parity independently influence expression of these genes of interest in the tissues studied', 'timeFrame': '1 - 2 years'}, {'measure': 'Determine the population variance for each gene of interest', 'timeFrame': '1 - 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to figure out some of the differences in bodily function between women who have preeclampsia and those who do not.\n\n* This may eventually lead to an understanding of its cause. At this time, there is no known way to prevent preeclampsia, and the cause is not known.\n* The only treatment is delivery of the baby, even if it is premature, in order to decrease the risk to the mother.', 'detailedDescription': '* Preeclampsia is a pregnancy-related disorder that occurs in about 6% of all pregnancies.\n* In its mild for, preeclampsia involves high blood pressure. More severe forms of preeclampsia can lead to more serious pregnancy complications.\n* At this time, there is no known way to prevent preeclampsia, and the cause is not known. The only treatment is delivery of the baby, even if it is premature, in order to decrease the risk to the mother.\n* The purpose of this study is to figure out some of the differences in bodily function between women who have preeclampsia and those who do not. This may eventually lead to an understanding of its cause.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gravidas at 32-42 weeks gestation who present to Labor and Delivery units at University of Rochester, Strong Memorial Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gravidas at 32-42 weeks gestation,who have preeclampsia as defined by Sibai et al, 1997.\n* Control patients: Gravidas without history of hypertension of any kind, and matched to cases for parity, gestational age, labor status, maternal age, and race.\n\nExclusion Criteria:\n\n* Prior betamethasone administration, fetal growth restriction (\\<3%ile), prior chronic hypertension (nonpregnant or \\< 20 weeks gestation any pregnancy), chorioamnionitis, major fetal anomaly or chromosome abnormality, multiple gestation, and maternal diabetes (any class except diet-controlled gestational).'}, 'identificationModule': {'nctId': 'NCT00919360', 'briefTitle': 'Gene Expression In Pregnancies Complicated by Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Expression of Vascular Endothelial Growth Factor and Its Effectors in Preeclampsia', 'orgStudyIdInfo': {'id': 'RSRB# 22086'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Controls', 'description': 'Gravidas without history of hypertension of any kind, and matched to cases for parity, gestational age, labor status, mode of delivery, maternal age, and race.', 'interventionNames': ['Procedure: collection of maternal blood specimen prior to delivery', 'Procedure: collection of placental cord blood after delivery', 'Procedure: collection of placental tissue', 'Procedure: collection of strip of decidua from uterine lining from cesarean section deliveries']}, {'label': 'Preeclamptics', 'description': 'Gravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997.', 'interventionNames': ['Procedure: collection of maternal blood specimen prior to delivery', 'Procedure: collection of placental cord blood after delivery', 'Procedure: collection of placental tissue', 'Procedure: collection of strip of decidua from uterine lining from cesarean section deliveries']}], 'interventions': [{'name': 'collection of maternal blood specimen prior to delivery', 'type': 'PROCEDURE', 'description': 'approximately 5 cc. of maternal blood will be drawn prior to delivery', 'armGroupLabels': ['Controls', 'Preeclamptics']}, {'name': 'collection of placental cord blood after delivery', 'type': 'PROCEDURE', 'description': 'approximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped', 'armGroupLabels': ['Controls', 'Preeclamptics']}, {'name': 'collection of placental tissue', 'type': 'PROCEDURE', 'description': 'within 10 minutes of delivery, the placenta will be radially transected, and a full-thickness slice from the central region removed using sterile technique by scalpel.This will be placed into a pre-prepared container of RNA preservation medium.', 'armGroupLabels': ['Controls', 'Preeclamptics']}, {'name': 'collection of strip of decidua from uterine lining from cesarean section deliveries', 'type': 'PROCEDURE', 'description': 'A strip of decidua will be removed from the upper lip of uterine incision by the surgeon and placed in RNA preservation medium.', 'armGroupLabels': ['Controls', 'Preeclamptics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Eva Pressman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Monique Ho', 'investigatorAffiliation': 'University of Florida'}}}}