Could a mother's virus raise her baby's heart defect risk? new study investigates.
NCT ID NCT04769167
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether viral infections and diabetes in pregnant women are linked to congenital heart defects in their babies. Researchers analyzed blood and stool samples from 114 women to detect viruses and immune responses. The goal was to gather knowledge for future larger studies, not to test a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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114 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Exclusion Criteria - All Cohorts 1. Women under the age of 18 or older than 45. 2. Prediabetes defined as an HbA1C between 5.7% and 6.5% or current diagnosis of pancreatic diabetes or gestational diabetes (GDM). 3. Body Mass Index greater than or equal to 35 or less than or equal to 18. 4. Women unable to give informed consent and/or considered a prisoner. 5. Use of any of the following drugs within the last 6 months: 5a.Systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); 5b.Cytokines; 5c. Immunomodulators or immunosuppressive cytotoxic agents; 5d. Large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply. 6\. A positive test for HIV, HBV or HCV or any confirmed or suspected condition/state of immunosuppression or immunodeficiency. 7\. History of autoimmune disorders other than T1D or treated thyroid disease. 8\. Major surgery of the GI tract, except for cholecystectomy and appendectomy, in the past five years. 9\. Any major bowel resection at any time. 10\. History of active uncontrolled gastrointestinal disorders or diseases including: 10a. Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), 10b. Crohn's disease (mild-moderate-severe), or indeterminate colitis; 10c. Irritable bowel syndrome (IBS) (moderate-severe); 10d. Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated). 11\. Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever. 12\. Use of assisted reproductive technology (ART)including but not limited to In vitro Fertilization (IVF), Gamete intrafallopian transfer (GIFT) and Zygote intrafallopian transfer (ZIFT). 13\. Any other condition which, in the opinion of the investigators, renders the patient unfit for study participation and procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
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St Louis Childrens Hospital
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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