The Fetal Institute of Miami, Florida, Conducting an FDA-monitored Clinical Trial to Investigate Minimally Invasive Fetoscopic Repair in Open Spina Bifida
MIAMI, July 8, 2021 /PRNewswire/ -- The Fetal Institute, Miami, which specializes in the assessment, counseling, and management of patients with high-risk pregnancies, is conducting a clinical trial of fetoscopic repair in open spina bifida, a minimally invasive procedure developed by doctors at the Institute and the USFetus in collaboration with colleagues in Brazil.
"This minimally invasive technique does not require opening the uterus," says Dr. Eftichia Kontopoulos, co-investigator. "As a result, not only can we treat the fetus, but the mothers are also able to deliver vaginally, not just for the affected pregnancy, but for all future pregnancies."
Open spina bifida (OSB), a birth defect that occurs in approximately 1 in 1,500 births in the United States, results from failure of the spine to close at some point along its length during fetal development, leading to injury and loss of spinal cord tissue at and below the defect.
Nowadays, fetal surgeons can correct OSB before the baby is born, preventing further damage as the pregnancy continues. However, with the open fetal surgery technique currently in use, the mother is at risk for rupture of the uterus (uterine rupture) that can be dangerous and requires delivery by cesarean section for the affected and any subsequent pregnancy.
Doctors at The Fetal Institute and the USFetus, in collaboration with colleagues in Brazil, have developed a minimally-invasive (fetoscopic) technique to treat fetuses with OSB that does not require opening the uterus. This allows the doctors to treat the fetus while allowing the mother to deliver vaginally and avoid complications, such as the risk of uterine rupture. The doctors are currently conducting an FDA-monitored clinical trial to validate this new fetoscopic technique for OSB repair.
To learn more about The Fetal Institute or to inquire about participating in this clinical trial, please click here or call (786)-971-2303.
About the Fetal Institute
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SOURCE The Fetal Institute