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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 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 114 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04769167
The ClinicalTrials.gov registry entry for NCT04769167 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Stool and Blood Specimen Collection is the first listed.
NCT04769167 reports 0 study locations.
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.
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