Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease
|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
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|