Study subjects.
infection
INFECTION
We performed this institutional review board (IRB)-approved study (WCG IRB number 1300043) at the Inova Health System in Northern Virginia under the US Food and Drug Administration (FDA) Investigational New Drug Application (IND) number 18076 (with an IND required by the FDA). We recruited pregnant women who were scheduled for an elective C-section at ≥37 weeks gestation and obtained written informed consent. We applied stringent inclusion and exclusion criteria to ensure the least risk of maternal-to-infant transmission of infection as discussed with the FDA and the exclusion of maternal health conditions associated with dysbiosis of the vaginal microbiome. For full details of inclusion and exclusion criteria, see supplemental data and 