Vaginal Seeding for Cesarean Section Babies

(MOTHER SEED Trial)

Recruiting in Nashville (>99 mi)

Overseen By Andrea E Lee, MA, MLS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Antibiotics, Immunosuppressives, Biologics, Chemotherapy

Disqualifiers: Diabetes, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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

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

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?

Group I: Intervention Group Active Control 1 Intervention

Vaginal Seeding

Group II: Control Group Placebo Group 1 Intervention

Sterile Swab

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The views of pregnant women in New Zealand on vaginal seeding: a mixed-methods study. Butler, ÉM., Reynolds, AJ., Derraik, JGB., et al.[2021]

Children born via Cesarean section may face higher risks for health issues like allergies, asthma, and obesity, leading to interest in vaginal seeding as a potential solution.

Vaginal seeding aims to transfer the mother's vaginal microbiome to C-section infants, showing some promise in restoring microbial exposure, but there is currently insufficient evidence to confirm its health benefits, with ongoing studies needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies. Mueller, NT., Hourigan, SK., Hoffmann, DE., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Committee Opinion No. 725 Summary: Vaginal Seeding. [2018]

A study involving 635 women who attempted vaginal birth after cesarean (VBAC) and 2593 control patients found that certain physician characteristics, such as lower cesarean rates and younger age, significantly increased the likelihood of successful VBAC.

Hospitals with high neonatal and obstetrical specialization also supported higher rates of VBAC, indicating that both physician and hospital factors play crucial roles in the adoption of this practice, which still shows considerable variability across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing the practice of vaginal birth after cesarean section. Goldman, G., Pineault, R., Potvin, L., et al.[2019]

In a study of 87 pregnant women with previous cesarean sections, 91.95% successfully achieved vaginal deliveries, indicating that vaginal delivery is feasible for this group under appropriate conditions.

There were no deaths reported, and while one case experienced a partial uterine rupture that was surgically repaired, the overall safety profile was positive, with most newborns scoring above 8 on the Apgar scale, suggesting good health at birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical management of vaginal delivery with previous cesarean section]. Huang, P., Liu, GB.[2008]

In a study of 346 preterm breech infants, those delivered vaginally had better arterial cord blood pH and base excess compared to those delivered by cesarean section, suggesting a potentially better fetal outcome for vaginal deliveries.

The findings indicate that there is no clear advantage of routine cesarean section over vaginal delivery for preterm breech infants, as many parameters were comparable, and the data do not support a policy favoring cesarean delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of fetal outcome in premature vaginal or cesarean breech delivery at 24-37 gestational weeks. Vidovics, M., Jacobs, VR., Fischer, T., et al.[2018]

A retrospective study of 1253 women with a previous cesarean section found that 54% successfully had a normal vaginal delivery, supporting vaginal delivery as a safe option for these patients when properly screened.

Importantly, there were no recorded cases of uterine scar rupture among the participants, indicating that with appropriate selection, vaginal delivery can be performed safely after a cesarean section.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications and contraindications for normal labor in patients who previously underwent cesarean section]. Cappa, F., D'Alfonso, A., Di Luzio, F., et al.[2017]

In a study of 1230 women who attempted a trial of labor after cesarean delivery, 76.8% successfully had an operative vaginal delivery, leading to a vaginal birth in 96.7% of those cases.

Attempted operative vaginal delivery was associated with a lower rate of endometritis compared to repeat cesarean delivery, and did not result in increased adverse maternal or neonatal outcomes, suggesting it is a safe and effective option for eligible women.

NCBI (Pubmed)

pubmed.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. Son, M., Roy, A., Grobman, WA.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Committee Opinion No. 725: Vaginal Seeding. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Manipulating the baby biome: What are the issues? [2017]

3. England pubmed.ncbi.nlm.nih.gov

The views of pregnant women in New Zealand on vaginal seeding: a mixed-methods study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Committee Opinion No. 725 Summary: Vaginal Seeding. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Factors influencing the practice of vaginal birth after cesarean section. [2019]

7. China pubmed.ncbi.nlm.nih.gov

[Clinical management of vaginal delivery with previous cesarean section]. [2008]

8. Germany pubmed.ncbi.nlm.nih.gov

Comparison of fetal outcome in premature vaginal or cesarean breech delivery at 24-37 gestational weeks. [2018]

9. Italy pubmed.ncbi.nlm.nih.gov

[Indications and contraindications for normal labor in patients who previously underwent cesarean section]. [2017]

10. United States pubmed.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]