Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-29 @ 5:45 AM
Study NCT ID:
NCT01603732
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2012-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01HL098634-02 | NIH | None | https://reporter.nih.gov/quic… | View |