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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01603732
First received: May 18, 2012
Last updated: June 11, 2014
Last verified: June 2014

May 18, 2012
June 11, 2014
January 2010
December 2014   (final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT01603732 on ClinicalTrials.gov Archive Site
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
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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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

Congenital Heart Disease in Pregnancy
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
505
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
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
United States
 
NCT01603732
201102410, 5R01HL098634-02
No
Washington University School of Medicine
Washington University School of Medicine
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Pirooz Eghtesady, MD,PhD Washington University School of Medicine and St Louis Children's Hospital
Washington University School of Medicine
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP