Clinical trial NCT01603732: Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease
Official title: Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease in Pregnancy
Keywords: Strep exposure and heart defects
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-05-23
Enrollment: 397
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Random Healthy Controls and Moms with fetal care/echos during pregnancy.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease
timeFrame: 01/15/2010 - 12/31/2014
Secondary outcomes:
measure: Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease
timeFrame: 01/15/2010 - 12/31/2014
Other outcomes:
Locations:
city: St Louis
country: United States
facility: St Louis Childrens Hospital
state: Missouri
city: Cincinatti
country: United States
facility: Cincinatti Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Washington University School of Medicine and St Louis Children's Hospital
name: Pirooz Eghtesady, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.