About this trial
This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children. Eligible children will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively). The main hypothesis is that conducting an RCT assessing the utility of vaginal seeding in modifying the early-life upper respiratory tract (URT) microbiome of children born by cesarean section (C-section) is feasible and that the intervention is safe.
Eligibility criteria
Qualifiers
Female 18-40 years of age who is in good general health, is fully able to provide consent to participate in the study, anticipates being available for the duration of the study, and is willing to comply with all study procedures
Singleton pregnancy
Completed ≧3 prenatal care visits at Vanderbilt University Medical Center (any facility)
Having rectovaginal swabs collected at ≧36 weeks of gestation to screen for Group B Streptococcus (GBS) as part of prenatal screening tests
Disqualifiers
Previous child with GBS infection or prior positive GBS testing
Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
Genital herpes simplex virus (HSV) infection, genital herpetic lesions, or prior positive genital HSV testing
Genital human papilloma virus (HPV) infection, genital HPV lesions, or prior positive genital HPV testing
Trial design
Treatments tested in this trial
- Vaginal Seeding
- Sterile Swab
Treatment groups
Sponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator