Women 18 or older with untreated fibroids who wish to receive treatment and avoid hysterectomy may be eligible to receive treatment through the study. Participants will be randomly assigned to receive one of the three treatments and will subsequently be required to attend the pre- and post-operative appointments that are standard to the assigned procedure. All three procedures – myomectomy, UAE, and RFVTA – have been cleared by the Food and Drug Administration for commercial use. All three methods are currently being utilized by US gynecologists for treating fibroids.

Inova Children's Hospital 3300 Gallows Road Falls Church, VA 22042

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.

The study is designed to assess the elasticity of pelvic floor muscles in women with varying degree of pelvic organ prolapse.