One to 5 percent of obstetric patients experience postpartum hemorrhage, a common, preventable event that accounts for 12 percent of maternal deaths in the United States, and about 25 percent of maternal deaths worldwide. Even more women suffer from abnormal postpartum uterine bleeding that requires treatment. When postpartum hemorrhaging or abnormal postpartum uterine bleeding occur, finding and treating the cause of bleeding as soon as possible is critical to the survival of the mother.
School of Public Health alum Kathryn Wine (SPH’02) is part of a team at Alydia Health, a California-based medical device company recently acquired by Merck spinoff and women’s healthcare company Organon, that received clearance from the US Food and Drug Administration on a groundbreaking device designed to control and treat postpartum hemorrhaging and abnormal postpartum uterine bleeding quickly. The device, called the Jada System, replicates the natural contraction of the uterus to stop excessive bleeding. Alydia created the non-invasive device in 2010 with a vision to make childbirth safe for all mothers.
Wine, who joined Alydia in 2018 as vice president of clinical operations and is now global director of medical affairs at Organon, is also a co-author of the published primary manuscript of the PEARLE study, which evaluated the Jada System and found that it is a safe and effective when used for this emergent condition. The study, published in the November 2020 issue of the journal Obstetrics & Gynecology, helped garner FDA clearance of the device.
“Every four minutes, a woman dies due to postpartum hemorrhaging,” says Wine, who studied epidemiology and biostatistics at SPH. “The Jada System is unique because it’s a physiologic approach to treating postpartum uterine bleeding, by assisting the uterus to do what it should do naturally after childbirth.”
Postpartum hemorrhage is most commonly caused by uterine atony, a condition that occurs when the uterus fails to contract and compress blood vessels after a baby is delivered, which can lead to excessive bleeding and become severe very quickly. Designed as a thin tube with a collapsible loop, the Jada System quickly controls bleeding by applying suction to the uterus once placed inside and connected to low-level vacuum. The clear device is connected to an in-line canister, so physicians are able to easily observe, monitor, and measure blood evacuation.
If a woman is treated definitively in a short amount of time, she can return to her recovery process and the important work of bonding with her newborn.
The PEARLE study was a prospective, multicenter study that enrolled 107 participants at 12 US hospitals with leading obstetric research centers. With her background in biotechnology and clinical pre-market and post-market research, Wine led relationship-building with each center and oversight of their participation in the study to ensure that the centers were able to collect the necessary data for FDA clearance. The pivotal study found that the Jada System was effective in controlling postpartum hemorrhage and abnormal postpartum uterine bleeding for 94 percent of patients in a median of three minutes. Almost all participating physicians (98 percent) reported that the device was easy to use, and 97 percent of the doctors said they would recommend it.
Ease of use of the device is key in medical emergencies involving excessive postpartum blood loss, says Wine. The study results show that “the Jada device works definitively to stop the bleeding, and our partners say that it brings calm back to the hospital room in a chaotic situation,” she says.
“If a woman is treated definitively in a short amount of time, she can return to her recovery process and the important work of bonding with her newborn,” says Wine. Furthermore, “providers can transfer her to a lower-resource setting where monitoring is not so costly, and move on to care for other patients. So the provider benefits, the healthcare system benefits, and most importantly, the woman can start her recovery process,” she says.
The Jada System is currently in a commercial expansion phase as the company continues to educate medical staff about the new device.
“Once a device is brought to market, it’s important to understand how it’s being used, and make sure that the outcomes we observed in the study continue to be positive in regular commercial use,” says Wine. “Alydia is also incredibly mission-driven, and part of our mission and commitment to investors is to make sure that we can offer this device globally. We’re working on a global product that can be used in low-resource settings, such as in sub-Saharan Africa where the rates of maternal mortality are the highest in the world.”
Wine credits the success of the Jada System, especially during the trial period, to “the human factor.
“The research on labor and delivery was incredibly challenging, but we chose the right partners and created deep relationships that enabled us to work openly with one another,” she says. “I’m so proud of my team at Alydia, and I’m humbled and fortunate to work with all of the amazing research centers on this important work.”