Novel Device Safely Treats Postpartum Hemorrhage after both Vaginal and Cesarean Births
Posted on 13 Feb 2023
The uterus is comprised of a network of muscle fibers in its middle layer, called the myometrium. When the placenta separates from the uterine wall following childbirth, that portion of the myometrium is left with open blood vessels, resulting in bleeding. Generally, the uterus contracts and the open vessels compress to stop the bleeding. However, in some cases, the uterine muscle fibers fail to contract, leading to uncontrolled bleeding, which is termed as abnormal postpartum uterine bleeding or postpartum hemorrhage and is a leading cause of maternal deaths worldwide. There have been limited innovations for the treatment of this condition in recent years. Now, a latest study has found a new tool for managing postpartum hemorrhage to be safe and effective in treating hemorrhage after both vaginal and cesarean births.
The Jada System, an intrauterine vacuum-induced hemorrhage control device from Organon (Jersey City, NJ, USA), received FDA clearance in August 2020 after the PEARLE IDE (investigational device exemption) study found the device to be safe and effective for treating postpartum hemorrhage. The IDE study involved 107 patients, most (85%) of whom had vaginal deliveries. In the new study aimed at reporting on the device’s safety and effectiveness in real-world use, researchers analyzed 800 individuals who were treated with the device from October 2020-April 2022. Out of these patients, 94.3% had uterine atony which is the most common cause of postpartum hemorrhage and occurs when the uterus fails to contract sufficiently to stop bleeding after childbirth.
The research team found that the device successfully treated postpartum hemorrhage in 92.5% of vaginal births and 83.7% of cesarean births. In a subset of the patients where time to bleeding control was captured, for vaginal births, the bleeding was controlled in 73.8% of patients within five minutes or less. In cesarean births, the bleeding was controlled in 62.2% of patients within five minutes or less. The mean indwelling time, or the average length of time from when the device was inserted into the uterus to when it was removed, was found to be 4.6 hours for vaginal births and 6.3 hours for cesarean births.
“What stood out in our study was that this device worked in real-world settings. It worked quickly and was highly effective in controlling postpartum hemorrhage, after both vaginal and cesarean birth, in a high proportion of patients. In addition, the device was safe and only had to remain in place for a few hours after placement allowing for a more streamlined postpartum care experience,” said the study’s lead author Dena Goffman, MD. “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.”
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