Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the Society for Maternal-Fetal Medicine (SMFM) 2023 Annual Pregnancy Meeting.
Dr Dena Goffman
“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York City, who presented the findings.
Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The US Food and Drug Administration (FDA) approved use of the Jada System in October 2020.
Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 US medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.
Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.
Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.
Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower income countries. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.
Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Goffman, she was excited to have a new tool for treating a life-threatening condition.
Although the device has been on the market for more than 2 years, Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.
“We should make sure that it’s effective, and we should know what the safety profile is,” said Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”
Both Goffman and Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.
“We should be supporting further investigation,” Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”
The study was funded by Alydia Health Inc, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Goffman serves on the scientific advisory board of Alydia Health/Organon. Samuel has disclosed no relevant financial relationships.
Society for Maternal-Fetal Medicine (SMFM) 2023 Annual Pregnancy Meeting: Abstract LB05. Presented February 10, 2023.
Ann Thomas is a pediatrician and epidemiologist living in Portland, Oregon.
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