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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603732
First Posted: May 23, 2012
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine
  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(CHD)

Resource links provided by NLM:


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 ]
    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 ]
    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.

Enrollment: 397
Study Start Date: January 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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 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.

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603732


Locations
United States, Missouri
St Louis Childrens Hospital
St Louis, Missouri, United States, 63110
United States, Ohio
Cincinatti Children's Hospital Medical Center
Cincinatti, Ohio, United States, 45229
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 ( U.S. NIH Grant/Contract )
First Submitted: May 18, 2012
First Posted: May 23, 2012
Last Update Posted: April 4, 2017
Last Verified: April 2017

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