Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes

You may not be if

• 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.