Coxsackie Virus in Pregnancy and Congenital Heart Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | March 1, 2016 |
| End Date: | December 31, 2020 |
| Contact: | Taylor C Merritt, BSN |
| Email: | t.merritt@wustl.edu |
| Phone: | 314-362-1729 |
Coxsackievirus Group B (CVB) Infection in Early Pregnancy
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)
increase in incidence of babies being born with congenital heart disease(CHD)
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.
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.
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) or Gestation is > 26 wks (UC) for visit
1.
- 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
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