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Vaginal Seeding for Cesarean Section Babies (MOTHER SEED Trial)
N/A
Recruiting
Led By Christian Rosas-Salazar, MD, MPH
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year following randomization
Awards & highlights
Summary
This trial tests if swabbing babies born by C-section with secretions from mom's vagina is safe and can modify their early-life microbiome.
Who is the study for?
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.
What is being tested?
The study tests if swabbing a newborn's nose with vaginal secretions after a C-section can safely alter the baby's upper respiratory microbiome. Infants are randomly assigned to receive either the vaginal seeding treatment or a sterile swab as control.
What are the potential side effects?
As this is an observational study focusing on feasibility and safety of the intervention (vaginal seeding), specific side effects are not anticipated beyond typical risks associated with handling newborns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year following randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year following randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of the RCT
Safety of the intervention
Secondary study objectives
Proportion of in-person study visits completed
Vagina
Timing of the intervention
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Intervention GroupActive Control1 Intervention
Vaginal Seeding
Group II: Control GroupPlacebo Group1 Intervention
Sterile Swab
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,894 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,167 Total Patients Enrolled
1 Trials studying Microbiome
50 Patients Enrolled for Microbiome
Christian Rosas-Salazar, MD, MPHPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking antibiotics or drugs that suppress my immune system.I or someone I live with had COVID-19 in the last 4 weeks.I do not have a fever or any signs of infection in my genital area today.I have had a fever of 100.4°F or higher in the last 3 days.I have been diagnosed with diabetes.I have had pelvic inflammatory disease.I am a healthy woman aged 18-40, can consent, and will follow the study rules.I am scheduled for a C-section due to an infection that prevents vaginal delivery.I have had hepatitis B, C, or HIV.I had symptoms like pain during urination, itching, or discharge suggesting an infection on the day I gave birth.I don't have any health issues that could affect my safety or participation in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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