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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

Awards & highlights

CHARMED Trial 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.Check my eligibility

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.See study design

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.

CHARMED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiotropic Virus Detection

Maternal Immune Response

Prevalence of EVB Viremia

CHARMED 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,298,307 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility for this research limited to certain individuals?

"Patients hoping to enroll in this trial will need to have gestational diabetes and be between the ages of 18-45. The study is currently looking for 1500 participants."

Answered by AI

To what extent is the current clinical trial administering treatments to participants?

"Affirmative. Clinicaltrials.gov's records show that the trial, which was first advertised on February 1st 2021, is actively enrolling participants at this time. There are 1500 available spots in total split between two different sites."

Answered by AI

Is there still room for volunteers to join this research endeavor?

"Absolutely, the clinicaltrial.gov website confirms that this experiment is actively enrolling individuals. Initially posted on February 1st 2021 and recently updated August 2nd 2022, it seeks to enrol 1500 patients across two facilities."

Answered by AI