Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT01603732
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2012-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Confirmation of maternal ß-hemolytic streptococcal \\& enterovirus infection(s) will be determined from nose and rectal swabs \\& blood samples assayed for standard marker antibodies to ß-hemolytic streptococcal \\& enterovirus exposure.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2012-05-18', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease', 'timeFrame': '01/15/2010 - 12/31/2014', 'description': 'History of strep infection using a detailed questionnaire and maternal medical records (primary end-point) and (b) maternal titers of the anti-strep antibody, anti-streptolysin O (ASO) (secondary endpoint).'}], 'secondaryOutcomes': [{'measure': 'Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease', 'timeFrame': '01/15/2010 - 12/31/2014', 'description': 'To determine if mothers of babies with HLHS have a significant history of strep infections'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Strep exposure and heart defects'], 'conditions': ['Congenital Heart Disease in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '16242853', 'type': 'BACKGROUND', 'citation': 'Eghtesady P. Hypoplastic left heart syndrome: Rheumatic heart disease of the fetus? Med Hypotheses. 2006;66(3):554-65. doi: 10.1016/j.mehy.2005.09.013. Epub 2005 Oct 20.'}, {'pmid': '15205431', 'type': 'BACKGROUND', 'citation': 'McGregor KF, Spratt BG, Kalia A, Bennett A, Bilek N, Beall B, Bessen DE. Multilocus sequence typing of Streptococcus pyogenes representing most known emm types and distinctions among subpopulation genetic structures. J Bacteriol. 2004 Jul;186(13):4285-94. doi: 10.1128/JB.186.13.4285-4294.2004.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to find out if there is any association between a mother\'s exposure to bacteria that normally causes "strep throat" and her baby\'s developing heart disease/heart defect.', 'detailedDescription': 'The primary objective of this study is to:\n\n1. measure maternal ß-hemolytic streptococcal carriage as defined by positive throat cultures in the absence of symptoms among Hypoplastic Left Heart Syndrome (HLHS) mothers.\n2. define the incidence of positive strep throat cultures among asymptomatic pregnant women, identified at \\<18 weeks gestation and followed to term.\n3. Measure antibodies that may cross react to select valvular/myocardial antigens in HLHS/Congenital Heart Defect(CHD)-other neonates born to mothers in the study\n4. determine serum and/or tissue reactivity against antibodies in matched maternal serum.\n\nThe secondary objectives of this study is to:\n\n1. measure maternal ß-hemolytic streptococcal serology using standard serology testing among HLHS mothers.\n2. determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among HLHS mothers.\n3. Determine "baseline" strep serologies and history of strep exposure among a cohort of asymptomatic pregnant women, identified at \\<18 weeks gestation and followed to term.\n\n The overall purpose of this study is to evaluate the history of β-hemolytic streptococcal pharyngeal exposure, groups A, G and C ("strep throat") in pregnant women whose pregnancies have been complicated by the diagnosis of congenital heart disease. Our short-term goal is to identify a potential association of an antecedent maternal strep throat exposure in pregnancy to identify a subset of heart defects\n4. To determine if co-infections play a role in congenital heart defects'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Random Healthy Controls and Moms with fetal care/echos during pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For Fetal pts:\n* HLHS or variant diagnosis\n* Other Congenital Heart Disease\n* Greater than or = 20wks gestation\n* For Healthy moms:\n* No diagnosis of Congenital Heart Disease\n* Greater than or = 20wks gestation\n\nExclusion Criteria:\n\n* For fetal pts \\& healthy controls:\n* Mom less than 18 years old\n* Twins or multiple gestations\n* Pregnancy affected by 2 or more congenital anomalies( in addition to heart defects)\n* Pregnancy affected by OB complications like pre-eclampsia\n* Known history of chromosomal anomaly or carrier status\n* Pregnancy result of fertility treatment including in vitro fertilization\n* Emotionally distress\n* Mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.'}, 'identificationModule': {'nctId': 'NCT01603732', 'briefTitle': 'Association Between a Mother\'s Exposure to "Strep Throat" and Her Baby\'s Developing Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)', 'orgStudyIdInfo': {'id': '201102410'}, 'secondaryIdInfos': [{'id': '5R01HL098634-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL098634-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Moms w HLHS or variant', 'description': "Mom's fetal diagnosis Hypoplastic Left Heart Syndrome/variant"}, {'label': 'Moms w/ Other congential heart defect)', 'description': 'Moms fetal diagnosis -other congenital heart defects'}, {'label': 'Moms-fetal - echo normal', 'description': 'Moms echo fetal diagnosis is normal.'}, {'label': 'Random Healthy Moms', 'description': 'Mom with healthy pregnancy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St Louis Childrens Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinatti Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Pirooz Eghtesady, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Washington University School of Medicine and St Louis Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}