Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease
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.
Congenital Heart Disease in Pregnancy
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)|
- Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease [ Time Frame: 01/15/2010 - 12/31/2014 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To determine if mothers of babies with HLHS have a significant history of strep infections
Biospecimen Retention: Samples With DNA
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.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603732
|Contact: Trupti S. Hathcock, BSNfirstname.lastname@example.org|
|Contact: Dee Dee F Epstein, BSNemail@example.com|
|United States, Missouri|
|St Louis Childrens Hospital||Recruiting|
|St Louis, Missouri, United States, 63110|
|Contact: Trupti S Hathcock, BSN 314-362-1729 firstname.lastname@example.org|
|Contact: Dee Dee Epstein, BSN 314-454-5311 email@example.com|
|United States, Ohio|
|Cincinatti Children's Hospital Medical Center||Terminated|
|Cincinatti, Ohio, United States, 45229|
|Principal Investigator:||Pirooz Eghtesady, MD,PhD||Washington University School of Medicine and St Louis Children's Hospital|