The study involves amniotic exchange, a procedure new to the U.S., in which surgeons remove caustic amniotic fluid from the uterus and replace it with sterile saline or lactated ringers solution. Introduced in Paris, France, the technique is the first to alter the makeup of amniotic fluid to treat fetal disorders.
Dr. Joseph Bruner, associate professor of obstetrics and gynecology and director of fetal diagnosis and therapy at Vanderbilt University Medical Center will perform the first amniotic exchange in the U.S. on July 5; two other study enrollees have been randomized at Vanderbilt as controls. Theres no doubt that as soon as the results of the study are published they will change the management of gastroschisis overnight, Bruner said.
Gastroschisis, diagnosed with ultrasound, occurs when a hole forms in a fetus abdominal wall. Part of the intestines protrude through the hole and spill into the uterus. As pregnancy advances, the amniotic fluid becomes toxic and harms parts of the fetus not designed to be exposed to it, such as internal organs. The intestines thicken, entangle and inflame. By 30 weeks, this fluid resembles liquid from a septic tank, Bruner said.
Standard therapy calls for these fetuses to be delivered early, often by cesarean section. But complications include longer than average times in costly neonatal intensive care units, longer times before their first feedings (requiring tube feeding) and between subsequent feedings, and longer waits until surgical correction.
In a pilot trial of 20 patients in Paris at the Maternity de lHopital Robert-Debre, simply removing the toxic amniotic fluid improved all outcomes 30% to 50 %. The babies were born at or near term with healthier intestines, had shorter intervals to surgery, shorter times to full feedings
Contact: Clinton Colmenares
Vanderbilt University Medical Center