Vacuum-induced device controls postpartum haemorrhage in just 5 mins
Uncontrolled postpartum haemorrhage (PPH) is a life-threatening complication of childbirth that is temporarily managed with uterine balloon tamponade. At SMFM 2023, researchers from the US presented findings for a new device that could control PPH safely and effectively in just 5 minutes.
Called the JADA system, the intrauterine vacuum-induced haemorrhage-control device successfully treated PPH in 92.5 percent of vaginal births (n=530) and 83.7 percent of caesarean births (n=270). [SMFM 2023, abstract LB05]
In a subset of patients where time to bleeding control was captured, bleeding in vaginal births was controlled in 73.8 percent of patients in ≤5 minutes. In caesarean births, bleeding was controlled in 62.2 percent of patients in ≤5 minutes.
Mean indwelling time, defined as the average length of time from when the device was inserted into the uterus to when it was removed, was 4.6 hours for vaginal births and 6.3 hours for caesarean births.
Three serious adverse events were reported that could have been related to the use of the device (two in vaginal births, one in caesarean birth).
More investigations should be supported
“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 presenting author Dr Dena Goffman from Columbia University’s Irving Medical Center in New York City, New York, US. “We should be supporting further investigation, but for people who have this tool available to them now, I think they can feel confident in using it.’’
Goffman and colleagues reviewed the medical charts of 800 women at 16 medical centres in the US, who used the device between October 2020 and April 2022. Of these patients, 94.3 percent had uterine atony.
Compared with balloon tamponade, Goffman said the vacuum device needed to stay in place for less time (3.1 hours for vaginal birth, 4.6 hours for caesarean birth), allowing women to recover faster.
Ease of use makes the device attractive
In the initial trial for the device undertaken at 12 centres in the US, 98 percent of clinicians reported that the device was easy to use, making it ideal for use in lower income countries. [Obstet Gynecol 2020; 136: 882–891]
The use of low-level vacuum (70–90 mm Hg) to contract the myometrium and decrease uterine size contrasts with traditional mechanical methods used for tamponade, which work by creating outward pressure, causing uterine distention, authors of the initial trial pointed out. “Active evacuation of blood and clot from the uterine cavity using low-level vacuum allows real-time quantification of blood loss throughout treatment. It does not require vaginal packing unlike in tamponade.”
“The device actually has potential for huge impact in low-income countries, given the high rates of maternal morbidity and mortality in those places,” added Goffman.
The device was first cleared by the US FDA in August 2020 based on the pivotal PEARLE investigational device exemption study. The current trial was to assess its safety and efficacy in a larger population of women with PPH in the real-world setting.
PPH is defined by the American College of Obstetricians and Gynecologists (ACOG) as a cumulative blood loss of >1,000 mL, with signs and symptoms of hypovolaemia within 24 hours of birth, regardless of vaginal or caesarean delivery.
The researchers said more data are warranted to persuade professional bodies like the ACOG to endorse the inclusion of the device for PPH in obstetric protocols.