Vaginal Microbiome Exposure and Immune Responses in C-section Infants

Inclusion Criteria:

• Pregnant woman must be able to understand and provide informed consent;

• Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grownfetus; and

• Atopic disease (asthma, allergic rhinoconjunctivitis, or atopic dermatitis) or foodallergy in a first-degree relative of the infant to-be-delivered (for exception, seeexclusion criteria*).

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 Foleycatheter).

For All Mothers and Their Infants:

• Inability or unwillingness of a participant to give written informed consent orcomply 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 ulcerativecolitis);

• Evidence of an active sexually transmitted infection (STI) (e.g., primary herpes orgenital warts, or trichomonas), yeast infection, or vaginosis on the day ofdelivery;

• Evidence of prior or current hepatitis B or C infection as demonstrated by thepresence of the hepatitis B surface antigen, antibody positivity against thehepatitis B core antigen, or antibody positivity against the hepatitis C virus;

--Assessment for active hepatitis B and hepatitis C infection will be repeated forthis study even if prior testing during the current pregnancy was negative;

• Evidence of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIVserology or detectable viral load);

• Positive Group B Streptococcus (GBS) test results by rectovaginal swab performedwithin 5 weeks of delivery, a prior infant with invasive GBS disease, or GBSbacteriuria at any point during pregnancy;

• Evidence of N. gonorrhoeae or C. trachomatis infection by testing performed within 5weeks of delivery;

• History of antibiotic administration during the third trimester of the currentpregnancy;

• 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 thanthe 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 isnot recommended;

• Current, diagnosed mental illness or current, diagnosed or self-reported drug oralcohol abuse in the mother that, in the opinion of the investigator, wouldinterfere 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 laboratorytesting 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.