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

This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01603732
First received: May 18, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Congenital Heart Disease in Pregnancy

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 infection will be determined from throat swabs from which colonies will be cultured& blood samples assayed for standard marker antibodies to ß-hemolytic streptococcal exposure


Estimated Enrollment: 505
Study Start Date: January 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moms w HLHS or variant
Mom's fetal diagnosis Hypoplastic Left Heart Syndrome/variant
Moms w/ other CHD(congential heart defect)
Moms fetal diagnosis of other congenital heart defects
Moms's fetal -normal
Moms who have had echos,fetal diagnosis is normal.
Random Healthy Moms
Mom's with healthy 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 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/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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Fetal pts:
  • HLHS or variant diagnosis
  • Other Congenital Heart Disease
  • Greater than or = 20wks gestation
  • Healthy moms:
  • Less than or = 18 weeks 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603732

Contacts
Contact: Trupti S. Hathcock, BSN 314-362-1729 hathcockt@wudosis.wustl.edu
Contact: Dee Dee F Epstein, BSN 314-454-5311 epsteind@wudosis.wustl.edu

Locations
United States, Missouri
St Louis Childrens Hospital Recruiting
St Louis, Missouri, United States, 63110
Contact: Trupti S Hathcock, BSN     314-362-1729     hathcockt@wudosis.wustl.edu    
Contact: Dee Dee Epstein, BSN     314-454-5311     epsteind@wudosis.wustl.edu    
United States, Ohio
Cincinatti Children's Hospital Medical Center Recruiting
Cincinatti, Ohio, United States, 45229
Contact: Mary Fisher     513-803-0127     Mary.Fisher@cchmc.org    
Sub-Investigator: Eric Michelfelder, MD            
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Pirooz Eghtesady, MD,PhD Washington University School of Medicine and St Louis Children's Hospital
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01603732     History of Changes
Other Study ID Numbers: 201102410, 5R01HL098634-02
Study First Received: May 18, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Strep exposure and heart defects

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 19, 2013