Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus
- Congenital Heart Disease
- Prenatal
- Diabetes
- Diabetes Mellitus - Type 1
- Diabetes Mellitus - Type 2
- Enterovirus
- Enterovirus Infections
- Viremia
- Heart Defects, Congenital
- Heart Diseases
- Pregnancy Complications
- Prenatal Infection
- Pregnancy in Diabetic
- Virus Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: All participants will provide the same biologic specimens (stool & blood) during their study arm's designated timeframe. All collected specimens will be analyzed per the study protocol.Masking: Single (Participant)Masking Description: All participant's will not know whether they had evidence of recent viremia as this analysis is conducted in the future and the diagnosis of enteroviral viremia does not impact clinical treatment.Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
To determine prevalence in non-pregnant women (i) the investigators will perform PCR analysis of stool and blood from a prospective cohort of 225 women with diabetes (and 225 without) and sequence the amplicons, and (ii) perform ELISA (IgM and IgG) analysis of sera collected concurrently. They will ...
To determine prevalence in non-pregnant women (i) the investigators will perform PCR analysis of stool and blood from a prospective cohort of 225 women with diabetes (and 225 without) and sequence the amplicons, and (ii) perform ELISA (IgM and IgG) analysis of sera collected concurrently. They will assay IgM/IgG positive samples for neutralizing antibodies. To determine prevalence in pregnant women (i) the investigators will perform PCR analysis of 1st trimester stool and blood from a prospective cohort of 450 women with diabetes (and 450 without diabetes) and sequence the amplicons, and (ii) perform ELISA (IgM and IgG) analysis of sera collected at 1st and 2nd or 3rd trimester. They will assay IgM/IgG positive samples for neutralizing antibodies. The investigators will also perform a comprehensive virome analysis using metagenomic shotgun sequencing with ViroCap enrichment, a method developed by co-PI, on 1st trimester stool samples from a subset (~4-500) of women (both EVB positive and negative) enrolled in Aim 1. The investigators will complement this data with VirScan® analysis of blood collected from the same women at 1st and 2nd/3rd trimester. VirScan® is a revolutionary new technique for comprehensive profiling of sera for antibodies against ~400 species and strains of pathogenic viruses.
Tracking Information
- NCT #
- NCT04769167
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Pirooz Eghtesady, MD, PhD Faculty
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