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

The Washington University

Status: Completed

Conditions: Congenital Heart Disease in Pregnancy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01603732

201102410

5R01HL098634-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 397 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

397 participants in 4 patient groups

Moms w HLHS or variant

Description:

Mom's fetal diagnosis Hypoplastic Left Heart Syndrome/variant

Moms w/ Other congential heart defect)

Description:

Moms fetal diagnosis -other congenital heart defects

Moms-fetal - echo normal

Description:

Moms echo fetal diagnosis is normal.

Random Healthy Moms

Description:

Mom with healthy pregnancy.

Sponsors of this trial

Lead Sponsor

The Washington University

Collaborating Sponsor

National Institutes of Health (NIH)