Vaginal Microbiome Exposure and Immune Responses in C-section Infants

Exclusion Criteria

• •For C-Section Mothers:
• •In labor with evidence of cervical change prior to the scheduled C-section;
• •Rupture of the amniotic sac; or
• •Vaginal pH \> 4.5 on the day of delivery.
• •For Vaginal Delivery Mothers:
• •\- Use of induction agents for cervical ripening (cervical prostaglandin or Foley catheter).
• •For All Mothers and Their Infants:
• •Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
• •History of moderate to severe atopic dermatitis within the past year in the mother;
• •Express no intention to breastfeed;
• •History of diabetes mellitus or gestational diabetes mellitus;
• •History of inflammatory bowel disease (IBD) (e.g., Crohn's Disease or ulcerative colitis);
• •Evidence of an active sexually transmitted infection (STI) (e.g., primary herpes or genital warts, or trichomonas), yeast infection, or vaginosis on the day of delivery;
• •Evidence of prior or current hepatitis B or C infection as demonstrated by the presence of the hepatitis B surface antigen, antibody positivity against the hepatitis B core antigen, or antibody positivity against the hepatitis C virus;
• •--Assessment for active hepatitis B and hepatitis C infection will be repeated for this study even if prior testing during the current pregnancy was negative;
• •Evidence of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV serology or detectable viral load);
• •Positive Group B Streptococcus (GBS) test results by rectovaginal swab performed within 5 weeks of delivery, a prior infant with invasive GBS disease, or GBS bacteriuria at any point during pregnancy;
• •Evidence of N. gonorrhoeae or C. trachomatis infection by testing performed within 5 weeks of delivery;
• •History of antibiotic administration during the third trimester of the current pregnancy;
• •Mothers with serious chronic conditions during pregnancy;
• •Mothers with complicated pregnancies including pre-eclampsia, chorioamnionitis, placenta previa, vasa previa, placental abruption, or active vaginal bleeding;
• •Maternal fever on the day of delivery (visit 0);
• •Infants with complications during delivery, such that the infant requires more than the standard neonatal resuscitation after delivery;
• •Infants delivered prior to 37 weeks of gestation;
• •Thick particulate meconium noted upon delivery of the infant;
• •Presence of a congenital abnormality in the infant for which study participation is not recommended;
• •Current, diagnosed mental illness or current, diagnosed or self-reported drug or alcohol abuse in the mother that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
• •Use of investigational drugs during the third trimester of pregnancy; or
• •Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator may:
• •* Pose additional risks from participation in the study,
• •* Interfere with the participant's ability to comply with study requirements, or
• •* May impact the quality or interpretation of the data obtained from the study.