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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease in Pregnancy

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

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • St Louis Childrens Hospital
  • Ohio
    • Cincinatti, Ohio, United States, 45229
      • Cincinatti Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Random Healthy Controls and Moms with fetal care/echos during pregnancy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Pirooz Eghtesady, MD,PhD, Washington University School of Medicine and St Louis Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 18, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Strep exposure and heart defects
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 201102410; 5R01HL098634-02 (U.S. NIH Grant/Contract)