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

Congenital Heart Disease in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603732
• Other study ID #: 201102410
• Secondary ID: 5R01HL098634-02
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: April 3, 2017
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease in Pregnancy
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
United States	Cincinatti Children's Hospital Medical Center	Cincinatti	Ohio
United States	St Louis Childrens Hospital	St Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Eghtesady P. Hypoplastic left heart syndrome: Rheumatic heart disease of the fetus? Med Hypotheses. 2006;66(3):554-65. Epub 2005 Oct 20. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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