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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL098634-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
The primary objective of this study is to:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Random Healthy Controls and Moms with fetal care/echos during pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Pirooz Eghtesady, MD,PhD | Washington University School of Medicine and St Louis Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Louis Childrens Hospital | St Louis | Missouri | 63110 | United States | ||
| Cincinatti Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16242853 | Background | 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. | |
| 15205431 | Background | 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. |
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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.
| Cincinnati |
| Ohio |
| 45229 |
| United States |