Vaginal Seeding for Cesarean Section Babies
(MOTHER SEED Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Do I need to stop my current medications to participate in the trial?
The trial does not specify if you need to stop taking your current medications. However, it excludes participants who have used certain medications like systemic antibiotics or immunosuppressive agents shortly before delivery, so it's best to discuss your specific medications with the trial team.
Is vaginal seeding safe for babies born via C-section?
What makes the treatment 'Vaginal Seeding' unique for cesarean section babies?
Who Is on the Research Team?
Christian Rosas-Salazar, MD, MPH
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for healthy infants born by C-section at VUMC, with mothers aged 18-40 intending to breastfeed and have pediatric care at VUMC. Exclusions include maternal infections like HIV or hepatitis, fever before delivery, use of certain antibiotics or immunosuppressives near delivery time, labor complications, and serious infant health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Nose swabbing with either maternal vaginal secretions or a sterile swab is performed immediately after birth
Follow-up
Participants are monitored for safety and effectiveness after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Sterile Swab
- Vaginal Seeding
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator