20 Participants Needed

Vaginal Seeding for Cesarean Section Babies

(MOTHER SEED Trial)

Recruiting in Nashville (>99 mi)
NR
MS
AC
AE
AE
Overseen ByAndrea E Lee, MA, MLS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Currently, there is not enough data to confirm the safety of vaginal seeding for C-section babies, and it should only be done as part of approved research studies.12345

What makes the treatment 'Vaginal Seeding' unique for cesarean section babies?

Vaginal Seeding is unique because it involves swabbing a cesarean-born baby with the mother's vaginal fluids to expose them to beneficial bacteria they would normally encounter during a vaginal birth, which is not a standard practice for cesarean deliveries.678910

Who Is on the Research Team?

CR

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

No intent to relocate outside the middle Tennessee region within 18-24 months of recruitment
Scheduled for a planned C-section due to a repeat C-section at VUMC (main campus only)
Intention to breastfeed partially or exclusively
See 4 more

Exclusion Criteria

Need for a switch from a planned C-section to an emergency C-section
I am currently taking antibiotics or drugs that suppress my immune system.
Onset of labor or rupture of membranes prior to delivery
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Immediately after birth

Intervention

Nose swabbing with either maternal vaginal secretions or a sterile swab is performed immediately after birth

Immediately following birth
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months
Multiple visits at birth, ~2 days, ~5 days, ~4 weeks, and ~6 months of age

What Are the Treatments Tested in This Trial?

Interventions

  • Sterile Swab
  • Vaginal Seeding
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Intervention GroupActive Control1 Intervention
Group II: Control GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

Vaginal seeding is a practice aimed at transferring maternal vaginal bacteria to newborns to promote healthy gut colonization and potentially reduce the risk of asthma and immune disorders, especially in infants born via cesarean delivery.
Currently, vaginal seeding should only be conducted within approved research protocols, as there is insufficient data on its safety and efficacy for widespread clinical use.
Committee Opinion No. 725: Vaginal Seeding.[2022]
The practice of 'vaginal seeding' aims to establish a baby's microbiome by transferring vaginal bacteria after a cesarean delivery, but it raises potential health risks that need to be carefully considered.
A harm minimization approach is recommended for managing women who request vaginal microbiome transfer, emphasizing the importance of informed decision-making and safety in this controversial practice.
Manipulating the baby biome: What are the issues?Lee, LY., Garland, SM., Giles, ML., et al.[2017]
A study involving 15 pregnant women in interviews and 264 women in an online questionnaire revealed that many view vaginal seeding positively, believing it could replicate natural birth processes and potentially benefit the infant gut microbiome.
If proven safe and effective, vaginal seeding could serve as a non-stigmatizing method to help prevent early childhood obesity in babies born via caesarean section, highlighting the need for maternity caregivers to stay informed about this practice.
The views of pregnant women in New Zealand on vaginal seeding: a mixed-methods study.Butler, ÉM., Reynolds, AJ., Derraik, JGB., et al.[2021]

Citations

Committee Opinion No. 725: Vaginal Seeding. [2022]
Manipulating the baby biome: What are the issues? [2017]
The views of pregnant women in New Zealand on vaginal seeding: a mixed-methods study. [2021]
Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies. [2021]
Committee Opinion No. 725 Summary: Vaginal Seeding. [2018]
Factors influencing the practice of vaginal birth after cesarean section. [2019]
[Clinical management of vaginal delivery with previous cesarean section]. [2008]
Comparison of fetal outcome in premature vaginal or cesarean breech delivery at 24-37 gestational weeks. [2018]
[Indications and contraindications for normal labor in patients who previously underwent cesarean section]. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Attempted operative vaginal delivery vs repeat cesarean in the second stage among women undergoing a trial of labor after cesarean delivery. [2022]
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