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Study record managers: refer to the Data Element Definitions if submitting registration or information.
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.
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 secretionsa medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed Women want sex Coxsackie virus. Note- Prior to April 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. Secondary Outcome Measures : Variables and trends influencing Congenital Heart Disease [ Time Frame: years ] Questionnaires and medical records: To for potential confounders of CVB serology through exploratory regression type analysis. Preliminary data is needed to investigate the relationship between variables and measured endpoints.
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Save this study. Warning You have reached the maximum of saved studies Coxsackie Virus in Pregnancy and Congenital Heart Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government.
Read our disclaimer for details. Last Update Posted : February 16, Study Description. 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:. FDA Resources.
Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. 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. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. The nomenclature, definition and classification of hypoplastic left heart syndrome. Cardiol Young. Left ventricular hypoplasia: a spectrum of disease involving the left ventricular outflow tract, aortic valve, and aorta.
J Am Coll Cardiol. Tissue-specific deletion of the coxsackievirus and adenovirus receptor protects mice from virus-induced pancreatitis and myocarditis. Cell Host Microbe. Cardiac deletion of the Coxsackievirus-adenovirus receptor abolishes Coxsackievirus B3 infection and prevents myocarditis in vivo.
Isolation of a common receptor for Coxsackie B viruses and adenoviruses 2 and 5. Epidemiology of noncomplex left ventricular outflow tract obstruction malformations aortic valve stenosis, coarctation of the aorta, hypoplastic left heart syndrome in Texas, Human placental trophoblasts confer viral resistance to recipient cells. Epub Jul 1. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Congenital Heart Disease in Pregnancy. Study Type :. Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. November 9, Key Record Dates.Women want sex Coxsackie
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Coxsackie Virus in Pregnancy and Congenital Heart Disease