Maternal Enteroviral Infection and Diabetes Impact on Congenital Heart Defects
(CHARMED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how viral infections in pregnant women might affect the development of heart defects in babies, focusing on those with diabetes. Researchers will collect and analyze blood and stool samples to understand the diversity of viruses in the gut and their potential link to congenital heart defects. Participants fall into four groups: healthy non-pregnant, diabetic non-pregnant, healthy pregnant, and diabetic pregnant women. Ideal participants are women not using certain medications, without specific health conditions, and not undergoing assisted reproductive technology.
As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance maternal and infant health outcomes.
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.
What prior data suggests that this study's methods are safe?
Research has shown that safety is crucial in clinical trials. In this study, researchers are not testing new drugs or treatments. Instead, they are collecting data and samples, such as blood and stool, from participants. This approach eliminates the risk associated with taking new medicines or undergoing medical procedures.
Because the study primarily involves sample collection and reviewing medical records, it is considered low risk. Participants do not receive experimental treatments that might have unknown side effects. The main safety concern is ensuring that sample collection is conducted carefully and safely.
Overall, the study is safe for participants, as it employs standard methods to collect samples without introducing new treatments.
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover the relationship between maternal enteroviral infections, diabetes, and congenital heart defects. Unlike standard approaches, which typically focus on genetic or environmental factors separately, this trial investigates how viral infections and diabetes during pregnancy might interact and contribute to heart defects in newborns. By collecting stool and blood samples and conducting detailed medical record reviews, researchers hope to pinpoint specific biomarkers or patterns that could lead to early detection and preventive strategies. This could pave the way for more targeted interventions and better outcomes for mothers and their babies.
What evidence suggests that this trial's approaches could be effective in understanding the link between maternal viral infections and congenital heart defects?
Research has shown that some viruses can affect how a baby's heart develops during pregnancy. For instance, during the Rubella epidemic, studies found that viral infections in pregnant women could cause birth defects, including heart problems in babies. This trial will explore the connection between viruses and heart defects by examining the viruses in the gut of participants across different study arms: Healthy Pregnant Women (HPW), Diabetic Pregnant Women (DPW), Healthy Non-Pregnant Women (HNPW), and Diabetic Non-Pregnant Women (DNPW). Some viruses may specifically target heart tissues. This research could clarify how these viruses might lead to heart defects in babies.
Who Is on the Research Team?
Pirooz Eghtesady, MD, PhD
Principal Investigator
Faculty
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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