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NCT04769167 · ClinicalTrials.gov registry record · NA
Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 114
- Enrollment target
NCT04769167: Completed NA study, sponsored by Washington University School of Medicine.
NCT04769167 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 114 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04769167, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 114 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Determine the prevalence of EVB among women with or without diabetes. For this aim, the investigators will use PCR analysis of stool and blood to detect EVB and ELISA (IgM and IgG) of blood to detect anti-EVB antibodies in samples collected from pregnant and non-pregnant women (with or without diabetes) at multiple time points. The investigators will also sequence the PCR amplicons and carry out antibody neutralization assays of IgM/IgG positive samples to identify the specific EVB. The non-preg
Interventions
- OTHER Stool and Blood Specimen Collection
- OTHER Follow-up Medical Record Review
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2023-12-05 |
| Phase | NA |
What the finished NCT04769167 record still lists
NCT04769167 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Stool and Blood Specimen Collection is the first listed.
NCT04769167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04769167 about?
NCT04769167 is a clinical study titled "Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes". 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 ...
What is the current status of trial NCT04769167?
This trial is currently completed. It is a NA study. The enrollment target is 114 participants. The study started on 2021-02-01. Estimated completion is 2023-12-05.
What interventions are being tested in trial NCT04769167?
The interventions under investigation include: Stool and Blood Specimen Collection (OTHER), Follow-up Medical Record Review (OTHER).
Who is sponsoring clinical trial NCT04769167?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04769167's enrollment target sits among peer trials
114 811th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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