Device is safe and effective in real-world setting, providing high treatment success for vaginal and cesarean births
By Elana Gotkine HealthDay Reporter
FRIDAY, Feb. 17, 2023 (HealthDay News) — The Jada System, an intrauterine vacuum-induced hemorrhage control device, is safe and effective in a real-world setting, according to a study presented at The Pregnancy Meeting, the annual meeting of the Society for Maternal-Fetal Medicine, held from Feb. 6 to 11 in San Francisco.
Dena Goffman, M.D., from the Columbia University Irving Medical Center in New York City, and colleagues reported on the real-world effectiveness and safety of the intrauterine vaccine-induced hemorrhage control device. Eight hundred individuals were treated with the device from October 2020 to April 2022; 94.3 percent had uterine atony.
The researchers found that treatment success was 92.5 and 83.7 percent for vaginal births and cesarean births, respectively. Treatment success was 95.8 and 88.2 percent for vaginal and cesarean births, respectively, where uterine atony was the sole cause of bleeding. The mean indwelling time (insertion to removal) was 4.6 and 6.3 hours for vaginal and cesarean births, respectively; after device removal, bleeding recurred in 2.8 and 4.1 percent for vaginal and cesarean births, respectively. In 49 percent of cases, time to bleeding control was available. Bleeding control was achieved in no more than five minutes in 73.8 and 62.2 percent of vaginal and cesarean births, respectively. Three serious events were deemed possibly related to the device or procedure.
“As clinicians, we need to have more options to treat this potentially life-threatening condition, and this device gives us another tool to add to our toolbox to optimize postpartum hemorrhage management,” Goffman said in a statement.
One author disclosed financial ties to Alydia Health/Organon; the study was funded by Alydia Health, which was acquired by Organon in 2021 and is the manufacturer of the Jada System.
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