Coxsackie Virus in Pregnancy and Congenital Heart Disease

The Washington University

Status

Completed

Conditions

Congenital Heart Disease in Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT03737006

201602122

Details and patient eligibility

About

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)

Full description

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.

Enrollment

122 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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