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8110 Gatehouse Road, Falls Church, VA 22042

Vaginal Microbiome Seeding and Health Outcomes in Caesarean-Delivered Neonates: A Randomized Controlled Trial

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03298334

Background Information

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. It is believed that the risk of diseases associated with CS delivery may be due to the lack of mother-to-newborn transfer of beneficial vaginal microbes at birth, which are known to play a role in immune and metabolic development. 

"Vaginal microbiome seeding,” the transfer of vaginal microbes from mother to baby, is a process that can restore the exposure of a CS-delivered newborn to their mother’s beneficial vaginal microbes. In a pilot study, vaginal microbiome seeding of CS- delivered newborns was associated with an increased abundance of bacteria typically missing or reduced in CS. However, this study was too small to determine effects on early childhood health outcomes such as obesity.

At the Inova Translational Medicine Institute (ITMI) we are conducting the first randomized controlled trial in vaginal microbiome seeding in newborns delivered by CS. ITMI 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. 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.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, Virginia 22042

Principal Investigator

Suchitra Hourigan, MD, Inova Translational Medicine Institute

Ineligibility Information

For more information visit: https://clinicaltrials.gov/ct2/show/NCT03298334?term=vaginal+seeding+suchitra+hourigan&rank=1