Maternal Enteroviral Infection and Diabetes Impact on Congenital Heart Defects
(CHARMED Trial)
Trial Summary
What is the purpose of this trial?
Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certainly no comprehensive study, especially using next generation sequencing (NGS), has been undertaken in this context. The current pandemic as well as those caused by Zika, influenza, Ebola and Lassa Fever (among many) have shown pregnant women and their baby are at high risk. Therefore, an open-minded approach is warranted when considering the role of maternal viral infections in CHD. Even less is known about maternal immune response, such as antibody production, to these viruses. The investigator's goal is to answer the above gaps in knowledge. The investigators propose to do that using two different approaches; one retrospective (analysis of samples in two existing, large biorepositories) and the other prospective. The investigator's have created a multi-disciplinary team to bring together the needed expertise from individuals who have overlapping and vested interest in this project. The investigator's specific aim is to examine the diversity of the gut virome in non-pregnant and pregnant women with and without diabetes, with special emphasis on known cardiotropic viruses (those with tropism for cardiac tissues). This study is seen by the investigator's as the first step prior to a larger prospective multi-institutional study to specifically assess the linkage between the maternal virome and CHD pathogenesis.
Will I have to stop taking my current medications?
The trial requires that you have not used certain medications like antibiotics, antifungals, antivirals, immunosuppressants, or large doses of probiotics in the last 6 months. If you are currently taking these, you may need to stop before participating.
Is the treatment for maternal enteroviral infection and diabetes impact on congenital heart defects safe for humans?
The research does not provide specific safety data for the treatment related to maternal enteroviral infection and diabetes impact on congenital heart defects. However, it discusses the risks associated with maternal diabetes and congenital heart defects, indicating that maternal diabetes can increase the risk of birth defects, but does not address the safety of any specific treatment.12345
Research Team
Pirooz Eghtesady, MD, PhD
Principal Investigator
Faculty
Eligibility Criteria
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.Timeline
Screening
Participants are screened for eligibility to participate in the trial
Prospective Cohort Analysis
PCR analysis of stool and blood from pregnant and non-pregnant women, and ELISA analysis of sera
Virome and VirScan Analysis
Comprehensive virome analysis using metagenomic shotgun sequencing and VirScan analysis of blood
Follow-up
Participants are monitored for safety and effectiveness after analysis
Treatment Details
Interventions
- Follow-up Medical Record Review
- Stool and Blood Specimen Collection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor