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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2017
Start Date:January 2010
End Date:December 2015

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

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.

The primary objective of this study is to:

1. measure maternal ß-hemolytic streptococcal carriage as defined by positive throat
cultures in the absence of symptoms among Hypoplastic Left Heart Syndrome (HLHS)
mothers.

2. define the incidence of positive strep throat cultures among asymptomatic pregnant
women, identified at <18 weeks gestation and followed to term.

3. 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

4. determine serum and/or tissue reactivity against antibodies in matched maternal serum.

The secondary objectives of this study is to:

1. measure maternal ß-hemolytic streptococcal serology using standard serology testing
among HLHS mothers.

2. determine the history of maternal ß-hemolytic streptococcal exposure using a study
questionnaire among HLHS mothers.

3. 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

4. To determine if co-infections play a role in congenital heart defects

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.
We found this trial at
2
sites
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mi
from
Cincinatti, OH
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St Louis, Missouri 63110
Phone: 314-362-1729
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from
St Louis, MO
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