It has been said that pregnancy and delivery are the only normal health conditions that generally require admission to a hospital and intensive medical interventions. While this is true for vaginal delivery, it is particularly true for babies born via Cesarean Section (C-Section). The rates for C-Section delivery is on the rise globally and is currently the standard means of delivery for nearly a third of babies born in the US, half born in China, and up to 80% in portions of Brazil(3).
As noted by M. Dominguez-Bello Et al(1) “Epidemiological studies, although not showing causality, have reported associations between C-section delivery and an increased risk of obesity, asthma, allergies and immune deficiencies” It is hypothesized that the increased risk for chronic illness may be driven by the failure of a new born baby to be inoculated with the mothers vaginal microbiota, which generally occurs after membrane rupture and during a vaginal delivery.
Dr. Dominguez-Bello further demonstrated that a mother’s vaginal microbiota could be collected and transferred to a baby born via C-Section, a process some refer to as ‘vaginal seeding’, and that said baby’s microbial profile then appeared more in line with babies born vaginally. While longitudinal studies will be needed to confirm the long term impact, there is excitement that the potential health gap between C-Section Delivery and Vaginal Delivery could be closed via vaginal seeding.
Unfortunately the documented means of vaginal seeding does not lend itself to universal standardization, does not preserve an aliquot for testing, is highly aerobic which may impact survival of anaerobic bacteria, and does not address colonization of all of the environments normally inoculated during a vaginal delivery. Dr. Dominguez-Bello states “Determining more effective approaches to transfer the maternal microbiota to newborns and, more importantly, establishing which keystone species newborn infants should acquire at birth, are important to replicating the beneficial effects provided by vaginal delivery in C-section–delivered infants.”
The Replete V device seeks to address the observed need for a more effective approach to vaginal seeding:
- Innovative patent pending design allows for process standardization between facilities and practitioners
- Familiar form and function to common medical equipment allows for ease of use and adoption
- No unique equipment required
- Designed with the input of an all-female panel to ensure the process would be minimally invasive, and well accepted/tolerated
- Customized transfer kit allows for testing aliquot preservation and targeted inoculation of: skin, oral, and nasal tissues
- Closed processing chamber minimizes oxygen exposure to protect the majority anaerobic bacteria(2)
When my wife and I became aware that our youngest daughter would require a planned C-Section delivery I started planning how we would conduct vaginal seeding. Unfortunately this was before Dr. Dominguez-Bello’s landmark study, and our daughter was rushed to the NICU quickly after delivery. Sadly we were not able to perform vaginal seeding. While we will never know if her allergies and digestive ailments could have been offset by vaginal seeding, it is a goal of Replete Biotics that future parents will have increased access to standardized vaginal seeding, whether they are in the ~15% of medically necessary C-Sections, or the ever growing population of elective C-Section deliveries.
- Dominguez-Bello, M. G., Jesus-Laboy, K. M., Shen, N., Cox, L. M., Amir, A., Gonzalez, A., . . . Clemente, J. C. (2016). Partial restoration of the microbiota of cesarean-born infants via vaginal microbial transfer. Nature Medicine Nat Med, 22(3), 250-253. doi:10.1038/nm.4039
- Larsen, B., & Monif, G. R. (2001). Understanding the Bacterial Flora of the Female Genital Tract. Clinical Infectious Diseases, 32(4). doi:10.1086/318710
- Neu, J., & Rushing, J. (2011). Cesarean Versus Vaginal Delivery: Long-term Infant Outcomes and the Hygiene Hypothesis. Clinics in Perinatology, 38(2), 321-331. doi:10.1016/j.clp.2011.03.008