Vaginal Microbiome Exposure and Immune Responses in C-section Infants

Prior treatment

• In labor with evidence of cervical change prior to the scheduled C-section;
• 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;
• 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;
• Infants delivered prior to 37 weeks of gestation;
• Use of investigational drugs during the third trimester of pregnancy; or

Other illness

• History of moderate to severe atopic dermatitis within the past year in the mother;
• 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 Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV serology or detectable viral load);
• 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;
• 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;

Lab values

• 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.

Other

• For C-Section Mothers:
• 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;
• Express no intention to breastfeed;
• 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;
• Thick particulate meconium noted upon delivery of the infant;
• Presence of a congenital abnormality in the infant for which study participation is not recommended;

• Pregnant woman must be able to understand and provide informed consent;
• Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus; and
• Atopic disease (asthma, allergic rhinoconjunctivitis, or atopic dermatitis) or food allergy in a first-degree relative of the infant to-be-delivered (for exception, see exclusion criteria\*).