Coxsackie Virus in Pregnancy and Congenital Heart Disease

Study Overview
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Brief Summary
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Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)

Detailed Description
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The investigator proposes that Coxsackievirus group B (CVB) infection in early pregnancy induces pathological changes in congenital heart defects. To test the hypothesis, it will be determined if the incidence of CVB infection in women with babies that are congenital heart defect-(CHD) affected pregnancies are higher than in control subjects. After informed consent participants will provide the following samples during one study visit: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab) and complete a study questionnaire Our 3 study groups are the following-Group 1 is Hypoplastic Left Heart Syndrome or HLHS effected pregnancies. Group 2 is OCHD- Other Congenital Heart Defects and Group 3 is Unaffected Controls (UC) also known as healthy controls. After informed consent participants will provide the following samples: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab). A health history review and questionnaire will also be obtained. Analysis of these samples(blood, stool and nose secretions), a medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed to virus. Note- Prior to April 2016- the protocol and the healthy control (HC)subjects group were enrolled to come in for three study visits at varying times in their pregnancy. Blood, nose and stool samples were obtained at all three visits.

Official Title
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Coxsackievirus Group B (CVB) Infection in Early Pregnancy

Conditions
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Congenital Heart Disease in Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Fetal echocardiogram demonstrating one of the following: Hypoplastic Left Heart Syndrome (HLHS) or variant, other congenital heart disease (OCHD), or unaffected control (UC) Gestation is ≥20 wks-fetal group (HLHS, OCHD) Subject is able and willing to give informed consent. Exclusion Criteria Subject is < 18 years of age. Subject is pregnant with twins or multiple gestations. Subject's pregnancy is affected by 3 or more congenital anomalies (in addition to the heart defect). Subject's pregnancy is affected by chromosomal anomalies (OCHD & UC groups) Maternal history of chromosomal anomaly (OCHD & UC groups) Infertility treatment for current/index pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-(HLHS) effected pregnancies<br>Consent,blood draw, nose swab, stool collection,questionnaire and review of medical records. | |
| 2-Other Congenital Heart Defect (OCHD)<br>Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records. | |
| 3-Healthy Controls (UC)<br>Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal prenatal and newborn Cox B viral strand identification | Virus identification: Comparison to VP1 sequences available in GenBank will be used to identify the strain of CVB in the isolates. | 3 - 5years | 
| Maternal prenatal and newborn Cox B antibody levels | Serum CVB antibody titers: Past or current CVB infection will be determined from titers (>/= 1:80) collected from stool, serum and a nasal swab. | 3 - 5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variables and trends influencing Congenital Heart Disease | Questionnaires and medical records: To account for potential confounders of CVB serology results through exploratory regression type analysis. Preliminary data is needed to investigate the relationship between variables and measured endpoints. | 3-5 years |