NCT04769167Befejeződött
Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 24.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 114 (tényleges)
- Első benyújtás
- 2021. febr. 14.
- Kezdés
- 2021. febr. 1.
- Elsődleges befejezés
- 2023. dec. 5.
- Fő szponzor
- Washington University School of Medicine
- NCT-szám
- NCT04769167
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 114
- 2021. febr. 1. és az elsődleges befejezés (2023. dec. 5.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- 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.
Laborértékek
- Prediabetes defined as an HbA1C between 5.7% and 6.5% or current diagnosis of pancreatic diabetes or gestational diabetes (GDM).
Életkor
- Women under the age of 18 or older than 45.
Egyéb
- Body Mass Index greater than or equal to 35 or less than or equal to 18.
- Women unable to give informed consent and/or considered a prisoner.
Életkor a regiszterben: 18 év – 45 év · Nem: csak nők · Egészséges önkénteseket is fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Barnes-Jewish Hospital Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | St Louis | Egyesült Államok | Ismeretlen állapot |
| St Louis Childrens Hospital Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | St Louis | Egyesült Államok | Ismeretlen állapot |
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