Coxsackie Virus in Pregnancy and Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease in Pregnancy

• Registration Number: NCT03737006
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Variables and trends influencing Congenital Heart Disease	3-5 years	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.

Trial Locations

Locations (1)

St Louis Childrens Hospital; 🇺🇸 Saint Louis, Missouri, United States