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Maternal Enteroviral Infection and Diabetes Impact on Congenital Heart Defects (CHARMED Trial)

N/A
Waitlist Available
Led By Pirooz Eghtesady, MD, PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years

Summary

This trial is looking at the role of maternal viral infections in Congenital Heart Disease (CHD). They will be looking at samples from two existing biorepositories and also doing a prospective study.

Who is the study for?
This trial is for pregnant women, both with and without diabetes, to explore the potential link between maternal viral infections and congenital heart defects (CHD) in babies. Women participating will have their stool and blood samples collected for analysis.
What is being tested?
The study aims to investigate the diversity of viruses present in the gut (gut virome) of pregnant women by collecting stool and blood specimens. It will use advanced sequencing techniques to identify any links between these viruses and CHD.
What are the potential side effects?
There are no direct side effects from participating in this study as it involves non-invasive specimen collection for research purposes only.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiotropic Virus Detection
Maternal Immune Response
Prevalence of EVB Viremia

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Diabetic Non Pregnant Women (DNPW)Active Control2 Interventions
DNPW are diabetic and not pregnant
Group II: Diabetic Pregnant Women (DPW)Active Control2 Interventions
DNPW are diabetic and currently pregnant
Group III: Healthy Non Pregnant Women (HNPW)Placebo Group2 Interventions
HNPW are healthy women and not pregnant
Group IV: Healthy Pregnant Women (HPW)Placebo Group2 Interventions
HNPW are healthy women and currently pregnant

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,342,762 Total Patients Enrolled
Pirooz Eghtesady, MD, PhDPrincipal InvestigatorFaculty

Media Library

Diabetic Non Pregnant Women (DNPW) Clinical Trial Eligibility Overview. Trial Name: NCT04769167 — N/A
Congenital Heart Disease Research Study Groups: Healthy Non Pregnant Women (HNPW), Diabetic Non Pregnant Women (DNPW), Healthy Pregnant Women (HPW), Diabetic Pregnant Women (DPW)
Congenital Heart Disease Clinical Trial 2023: Diabetic Non Pregnant Women (DNPW) Highlights & Side Effects. Trial Name: NCT04769167 — N/A
Diabetic Non Pregnant Women (DNPW) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04769167 — N/A
~31 spots leftby Feb 2025
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