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 February 6 to 11 in San Francisco.
Dena Goffman, MD, 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% had uterine atony.
The researchers found that treatment success was 92.5 and 83.7% for vaginal births and cesarean births, respectively. Treatment success was 95.8 and 88.2% 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% for vaginal and cesarean births, respectively. In 49 % of cases, time to bleeding control was available. Bleeding control was achieved in no more than 5 minutes in 73.8 and 62.2% 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.