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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)

Conditions
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Congenital Heart Disease in Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Fetal pts: HLHS or variant diagnosis Other Congenital Heart Disease Greater than or = 20wks gestation For Healthy moms: No diagnosis of Congenital Heart Disease Greater than or = 20wks gestation Exclusion Criteria: For fetal pts & healthy controls: Mom less than 18 years old Twins or multiple gestations Pregnancy affected by 2 or more congenital anomalies( in addition to heart defects) Pregnancy affected by OB complications like pre-eclampsia Known history of chromosomal anomaly or carrier status Pregnancy result of fertility treatment including in vitro fertilization Emotionally distress Mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moms w HLHS or variant<br>Mom's fetal diagnosis Hypoplastic Left Heart Syndrome/variant | |
| Moms w/ Other congential heart defect)<br>Moms fetal diagnosis -other congenital heart defects | |
| Moms-fetal - echo normal<br>Moms echo fetal diagnosis is normal. | |
| Random Healthy Moms<br>Mom with healthy pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease | 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). | 01/15/2010 - 12/31/2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease | To determine if mothers of babies with HLHS have a significant history of strep infections | 01/15/2010 - 12/31/2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strep exposure and heart defects