Clinical trial NCT03737006: Coxsackie Virus in Pregnancy and Congenital Heart Disease
Official title: Coxsackievirus Group B (CVB) Infection in Early Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease in Pregnancy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Woman whose babies have been diagnosed with CHD ( a congenital heart defect) and controls (pregnant women babies without CHD).

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.

Eligibility 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

Primary outcomes:
measure: Maternal prenatal and newborn Cox B viral strand identification
timeFrame: 3 - 5years
measure: Maternal prenatal and newborn Cox B antibody levels
timeFrame: 3 - 5years
Secondary outcomes:
measure: Variables and trends influencing Congenital Heart Disease
timeFrame: 3-5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St Louis Childrens Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Pirooz Eghtesady, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bergelson JM, Cunningham JA, Droguett G, Kurt-Jones EA, Krithivas A, Hong JS, Horwitz MS, Crowell RL, Finberg RW. Isolation of a common receptor for Coxsackie B viruses and adenoviruses 2 and 5. Science. 1997 Feb 28;275(5304):1320-3. doi: 10.1126/science.275.5304.1320.
citation: McBride KL, Marengo L, Canfield M, Langlois P, Fixler D, Belmont JW. Epidemiology of noncomplex left ventricular outflow tract obstruction malformations (aortic valve stenosis, coarctation of the aorta, hypoplastic left heart syndrome) in Texas, 1999-2001. Birth Defects Res A Clin Mol Teratol. 2005 Aug;73(8):555-61. doi: 10.1002/bdra.20169.
citation: Delorme-Axford E, Donker RB, Mouillet JF, Chu T, Bayer A, Ouyang Y, Wang T, Stolz DB, Sarkar SN, Morelli AE, Sadovsky Y, Coyne CB. Human placental trophoblasts confer viral resistance to recipient cells. Proc Natl Acad Sci U S A. 2013 Jul 16;110(29):12048-53. doi: 10.1073/pnas.1304718110. Epub 2013 Jul 1.