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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

397 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Congenital Heart Disease in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moms w HLHS or variant

Mom's fetal diagnosis Hypoplastic Left Heart Syndrome/variant

No interventions assigned to this group

Moms w/ Other congential heart defect)

Moms fetal diagnosis -other congenital heart defects

No interventions assigned to this group

Moms-fetal - echo normal

Moms echo fetal diagnosis is normal.

No interventions assigned to this group

Random Healthy Moms

Mom with healthy pregnancy.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes