Inova clinical trial investigates outcomes of exposing newborns to mother’s microbes
While Caesarean section (CS) delivery can be lifesaving for both new mothers and their babies, children born by CS have an approximately 50 percent increased risk of childhood obesity, along with asthma and allergies. There is a marked difference between the microbiomes, the community of microorganisms that live in and on our bodies, of babies born vaginally and by CS, which raises questions in the medical research community. The increased risks of diseases associated with CS delivery could be due to the lack of mother-to-newborn transfer of beneficial vaginal microbes at birth.
The Inova Translational Medicine Institute team’s new research study Vaginal Microbiome Seeding and Health Outcomes in Caesarean-Delivered Neonates: A Randomized Controlled Trial seeks to assess whether the risks of diseases associated with CS delivery can be reduced during a process known as vaginal microbiome seeding, where a sample of the mother’s vaginal microbiome is swabbed onto her baby’s face and body shortly after delivery. The first newborn involved in Inova’s study was born on August 3 at Inova Fairfax Hospital.
The hope is that vaginal seeding will restore the important exposure to beneficial maternal vaginal microbes that a baby would typically be exposed to during vaginal birth.
The human microbiome is comprised of trillions of microorganisms, and these microbes could play an important role in immune and metabolic development, including reducing a baby’s risk of obesity, asthma and allergies, according to Suchi Hourigan, MD, Inova physician and principal investigator for the project. “If vaginal microbiome seeding is shown to decrease the risk of adverse childhood health outcomes in newborns born by CS, this could improve the health of our children and change the practice of obstetrics as we know it,” explained Hourigan. “Physicians would be able to provide life-saving care with CS, but reduce associated health outcome risks to the baby, using an inexpensive and easy process.”
This study is the first randomized controlled trial in vaginal microbiome seeding in newborns delivered by CS, and the first trial of its kind allowed to proceed by the FDA. Prior studies on vaginal seeding outside the United States have been limited in sample size and research period. The Inova Translational Medicine Institute’s study aims to include 800 mothers and babies and will thoroughly document each baby’s health throughout his or her first three years of life to fully examine microbiome development and childhood health outcomes through regular stool samples and health screenings.
“There is growing interest in vaginal seeding amongst mothers having CS,” said Hourigan. With any new study, the risks must also be carefully studied.
According to Hourigan, “the American College of Obstetrics and Gynecology (ACOG) has cautioned against vaginal seeding until more is known about long-term outcomes from an institutional review board (IRB)-approved research study. This is exactly what our study, which has been allowed to proceed by the IRB and the FDA, aims to do with very close monitoring of mother and baby and strict inclusion and exclusion criteria to minimize risks.”
Ruth Sangra, a nurse at Inova and the first mother involved in the vaginal seeding study, was initially interested in the process after researching more natural CS options. “There seemed to be some evidence already of [vaginal seeding] having good outcomes for our babies. As a nurse and specifically as a mom, I feel that this is an easy way I can help my child and other children to better their health,” said Sangra. “I hope that in the long run all CS babies and moms will have the opportunity to use this method and take advantage of the health benefits.”
If you’re interested in participating in Inova’s vaginal seeding research or would like to learn more, please visit NIH Clinical Trials or contact Dr. Suchi Hourigan, Director of Microbiome Research at ITMI, at 703-776-8199.