Real-world data affirm effectiveness of vacuum-controlled device for obstetric bleeding

The FDA-approved intrauterine vacuum-induced haemorrhage-control device rapidly controls bleeding in both vaginal and caesarean births, with a safety profile consistent with that observed in the registrational trial, as shown in a postmarket registry medical record review study.

Called the Jada System, the device has a soft silicone loop that is inserted into the uterus. When connected to a low-level vacuum, the loop helps the uterus to contract, which controls bleeding after childbirth. [https://www.organon.com/product/usa/pi_circulars/j/jada/jada_system_ifu_blue_seal.pdf; Expert Rev Med Devices 2021;18:849-853]

Data from 800 women who were treated with the Jada System across 16 centres in the United States showed that bleeding was successfully controlled in 92.5 percent of 530 vaginal births and in 83.7 percent of 270 caesarean births. Treatment success rates were consistent across the subgroups of women defined by the causes of postpartum haemorrhage: uterine atony with other bleeding causes, isolated uterine atony, and other or nonatony bleeding causes. [Obstet Gynecol 2023;doi:10.1097/AOG.0000000000005366]

For vaginal births, the median indwelling time (eg, insertion to removal of device) was 3.1 hours, with bleeding recurring after device removal in 2.8 percent women. For caesarean births, the median indwelling time was 4.6 hours, and bleeding recurrence occurred in 4.1 percent of women. These indwelling times, according to the investigators, were relatively shorter than what has been recorded for balloon tamponade. [Expert Rev Med Devices 2021;18:849-853]

In terms of safety, 14 serious adverse events (SAEs) occurred among 13 women (2.5 percent) with vaginal births and 22 SAEs among 21 (7.8 percent) of those with caesarean births.

Three SAEs (0.4 percent) were possibly related to the Jada System or the procedure. Two of these SAEs were endometritis, both occurring in the vaginal birth group and resolved with antibiotics. The third SAE was haemorrhagic shock in a woman with uterine atony and retained placenta who had emergent caesarean birth after being induced at 41 weeks of gestation. This event was managed with balloon tamponade and transfusion.

None of the women had uterine perforations or died.

“The safety profile was consistent with that observed in the registrational trial, and all events were expected risks in the setting of postpartum haemorrhage and resolved without serious complications, suggesting an acceptable risk-benefit profile,” according to the investigators.

Of the 800 women included in the study, the mean age was 30.3 years. Most were White (73.4 percent), 44.5 percent were nulliparous before the current delivery, 6 percent delivered before term, and 10 percent had a history of abnormal postpartum bleeding. Median total blood loss at Jada System insertion was 1,050 mL in vaginal births and 1,600 mL in caesarean births.

“Early recognition of abnormal postpartum bleeding and timely intervention are crucial in managing the condition and preventing severe maternal morbidity associated with excessive blood loss. Whether postpartum haemorrhage is defined as ≥1,000 mL of blood loss regardless of delivery route or 500–999 mL of blood loss in the setting of vaginal births and more than 1,000 mL in the setting of caesarean births, most cases in this study exceeded those thresholds before device insertion,” the investigators noted.

“The blood loss volumes before the insertion of the device, together with the elapsed time from placenta delivery to device insertion [median, 31 and 108 minutes in the vaginal and caesarean birth groups, respectively], suggests either a delay in the recognition of obstetric haemorrhage or a delay in implementation of effective treatment measures,” they added.

Together, these data indicate that the Jada System may be an important new tool for managing a life-threatening condition and that using the device promptly should improve obstetric haemorrhage outcomes and ultimately minimize maternal morbidity and mortality, the investigators said.