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Completed

NCT Number: NCT03737006

Coxsackie Virus in Pregnancy and Congenital Heart Disease

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)

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Key information

Conditions

Congenital Heart Disease in Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St Louis Childrens Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Maternal prenatal and newborn Cox B viral strand identification

    Time frame: 3 - 5years

    Virus identification: Comparison to VP1 sequences available in GenBank will be used to identify the strain of CVB in the isolates.

  2. Maternal prenatal and newborn Cox B antibody levels

    Time frame: 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.

Secondary outcomes

  1. Variables and trends influencing Congenital Heart Disease

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Coxsackievirus Group B (CVB) Infection in Early Pregnancy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2018
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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