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Completed

NCT Number: NCT01603732

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St Louis Childrens Hospital, St Louis, Missouri, United States

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About this study

The primary objective of this study is to:

  • measure maternal ß-hemolytic streptococcal carriage as defined by positive throat cultures in the absence of symptoms among Hypoplastic Left Heart Syndrome (HLHS) mothers.
  • define the incidence of positive strep throat cultures among asymptomatic pregnant women, identified at <18 weeks gestation and followed to term.
  • 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
  • determine serum and/or tissue reactivity against antibodies in matched maternal serum.

The secondary objectives of this study is to:

  • measure maternal ß-hemolytic streptococcal serology using standard serology testing among HLHS mothers.
  • determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among HLHS mothers.
  • 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

  • To determine if co-infections play a role in congenital heart defects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 23, 2012
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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