Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease
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|ClinicalTrials.gov Identifier: NCT01603732|
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : April 4, 2017
|Condition or disease|
|Congenital Heart Disease in Pregnancy|
The primary objective of this study is to:
- measure maternal ß-hemolytic streptococcal carriage as defined by positive throat cultures in the absence of symptoms among Hypoplastic Left Heart Syndrome (HLHS) mothers.
- define the incidence of positive strep throat cultures among asymptomatic pregnant women, identified at <18 weeks gestation and followed to term.
- 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
- determine serum and/or tissue reactivity against antibodies in matched maternal serum.
The secondary objectives of this study is to:
- measure maternal ß-hemolytic streptococcal serology using standard serology testing among HLHS mothers.
- determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among HLHS mothers.
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.
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
- To determine if co-infections play a role in congenital heart defects
|Study Type :||Observational|
|Actual Enrollment :||397 participants|
|Official Title:||Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Moms w HLHS or variant
Mom's fetal diagnosis Hypoplastic Left Heart Syndrome/variant
Moms w/ Other congential heart defect)
Moms fetal diagnosis -other congenital heart defects
Moms-fetal - echo normal
Moms echo fetal diagnosis is normal.
Random Healthy Moms
Mom with healthy pregnancy.
- Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease [ Time Frame: 01/15/2010 - 12/31/2014 ]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).
- Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease [ Time Frame: 01/15/2010 - 12/31/2014 ]To determine if mothers of babies with HLHS have a significant history of strep infections
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603732
|United States, Missouri|
|St Louis Childrens Hospital|
|St Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cincinatti Children's Hospital Medical Center|
|Cincinatti, Ohio, United States, 45229|
|Principal Investigator:||Pirooz Eghtesady, MD,PhD||Washington University School of Medicine and St Louis Children's Hospital|