We need to study how to integrate the device into a health system so that good uptake, appropriate use, and best practice result in quality care. Thomas Burke, MD

Director, Global Health Innovation Lab

Department of Emergency Medicine

Massachusetts General Hospital

BOSTON – According to the World Health Organization’s latest statistics, from 2017, more than 800 women around the world die every day from preventable causes related to pregnancy and childbirth — the vast majority of them in resource-poor areas. The leading reason is postpartum hemorrhage (PPH), which accounts for 27 percent of maternal mortality and occurs to some degree in five to seven percent of all deliveries.

Advanced interventions to stop the bleeding before the problem becomes unmanageable include emergency hysterectomy, a particular suturing technique, and ligation or embolization of the uterine artery — but because these require extensive training and/or high-tech equipment, not all hospitals around the world have access to them. A simple, inexpensive alternative, the uterine balloon tamponade (UBT), has been available since the early 1980s. In it, a balloon is inserted through the cervix by catheter and inflated with water, filling the uterine cavity and arresting the hemorrhage.

Two studies — published in 2013 and 2019 — brought into question the effectiveness of UBT, but a paper published today in the American Journal of Obstetrics and Gynecology “really puts a nail in that coffin,” according to principal investigator Thomas Burke, MD, FACEP, FRSM, director of the Global Health Innovation Lab in the Emergency Department at Massachusetts General Hospital and an associate professor at Harvard Medical School and the Harvard T.H. Chan School of Public Health.

“The reason we undertook this study is that those two trials caused a great deal of confusion and controversy regarding UBT,” Burke said. “We decided to take an extremely rigorous approach, bringing together all of the world’s literature on this technique and inviting independent investigators to join. It was a massive project.” Burke and his colleagues conducted a systematic review and meta-analysis of 91 randomized control trials, nonrandomized studies, and case series, and found an overall success rate of 85.9 percent for UBT.

“So what this really teaches us is that the challenges experienced in these two trials were about the program implementation, not the device itself,” he said. “There’s no question the device works fine. But saving a life is much more complex than just handing someone a device that’s new to their practice. We need to study how to integrate the device into a health system so that good uptake, appropriate use, and best practice result in quality care.”

Burke pointed out that it is “exquisitely clear” that in many areas of the world, maternal mortality drops significantly when UBT is used. “They have saved many lives,” he said. “But there are still places where one in six women lose their lives from pregnancy-related causes and in 2020 that should never be. It’s an embarrassment to humankind.”

The study’s co-authors are Sebasian Suarez, MD, MPH, Daniela Suarez-Rebling, BS, and Melody Eckardt, MD, MPH, all of the Global Health Innovation Lab in the Department of Emergency Medicine at MGH; Agustin Conde-Agudelo, MD, MPH, PhD, of the Perinatal Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health and the Department of Health and Human Services, Bethesda, Maryland; Anderson Borovac-Pinheiro, MD, PhD, of MGH’s Global Health Innovation Lab and the Department of Obstetrics and Gynecology at Brazil’s University of Campinas; and Gerhard Theron, MD, of Department of Obstetrics and Gynecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa .

About the Massachusetts General Hospital

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $1 billion and comprises more than 8,500 researchers working across more than 30 institutes, centers and departments. In August 2019 the MGH was once again named #2 in the nation by U.S. News & World Report in its list of "America’s Best Hospitals."