In the study, investigators analyzed the Jada System in 800 patients from October 2020 to April 2022 across 16 hospitals in the United States. Results of the study were presented at the SMFM 43rd Annual Pregnancy Meeting in San Francisco, California.
Postpartum hemorrhage is one of the top causes of maternal death; however, in recent years, new devices and treatments have entered the market to combat this issue.
One device, in particular, has demonstrated positive data, which was recently presented at the Society for Maternal-Fetal Medicine’s (SMFM) 43rd Annual Pregnancy Meeting held February 6-11 in San Francisco, California, as well as published in the American Journal of Obstetrics and Gynecology.
The Jada System (Organon) is an intrauterine vacuum-induced hemorrhage control device that was FDA-cleared in August 2020 following results from the PEARLE IDE (investigational device exemption) study. These study results found that the Jada System was safe and effective for treating postpartum hemorrhage. Additionally, this study examined the device in 107 patients who delivered vaginally and 15 who had a cesarean delivery.
Now, a new study has been conducted to examine the safety and efficacy of the device in a larger group within a real-world setting. In the study, investigators analyzed the Jada System in 800 patients from October 2020 to April 2022 across 16 hospitals in the United States. Over 94% of patients had uterine atony, which is one of the leading causes of postpartum hemorrhage.
Results of the study showed that the Jada System was successful at treating postpartum hemorrhage in vaginal and cesarean births, 92.5% and 83.7%, respectively. The mean indwelling time was 4.6 hours for vaginal births and 6.3 hours for cesarean births. Also, when the time to bleeding control was captured, bleeding was controlled within 5 minutes in 73.8% of vaginal births and 62.2% 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 lead author Dena Goffman, MD, a maternal-fetal medicine subspecialist and professor and vice chair for quality and patient safety in the Department of Obstetrics and Gynecology at Columbia University Irving Medical Center in New York.
Goffman concluded, “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.”
First large real-world study of FDA-cleared device to treat postpartum hemorrhage finds device highly safe and effective. Society for Maternal-Fetal Medicine. February 10, 2023. Accessed February 10, 2023/ https://www.eurekalert.org/news-releases/979134