Postpartum hemorrhage remains a leading cause of maternal deaths worldwide; however, “nearly all of these deaths could be prevented by timely and appropriate management,” wrote Maria I. Rodriguez, MD, of Oregon Health & Science University, Portland, and colleagues. Other strategies including use of sterile gauze, inflated Foley catheters, condom catheters, and silicone obstetric balloons, have been tried in the management of postpartum hemorrhage, but are not ideal, the researchers said.
The investigators adapted a mini-sponge device originally designed for trauma and conducted a study of a prototype between May 20 and June 12, 2019, at a single site in Zambia.
“To adapt the mini-sponge device for use in the treatment of postpartum hemorrhage, we developed an obstetric applicator for transcervical placement using a digital vaginal route,” the researchers explained. The sponges are made of the same material used in standard surgical sponges and approved for use inside the uterus and vagina, they added.
In a study published in Obstetrics & Gynecology, the investigators assessed placement, removal, and preliminary efficacy of the device. Eligible patients were women aged 16 years and older who experienced postpartum hemorrhage with an estimated blood loss of 500 mL or more because of atony after vaginal delivery.
The device was successfully placed in nine patients, and bleeding resolved within 1 minute. “For all participants, bleeding stopped in less than 1 minute, did not recur, and required no further treatment,” the researchers said.
The average time to device placement was 62 seconds. The sponges were left in place from 0.5 hours to 14 hours with an average of 1 hour, and patients were monitored with physical, visual, and ultrasound to confirm the cessation of bleeding.
Evidence of safety
No device-related adverse events were reported, and patients remained afebrile while using the device. The average age of the patients was 29 years; three had a history of anemia and four were living with HIV. One patient received a blood transfusion during labor prior to hemorrhage.
The study findings were limited by the small sample size, the low threshold for diagnosing postpartum hemorrhage, and use of estimated blood loss, which is less precise than quantitative blood loss assessment, the researchers noted. However, the results support the use of the mini-sponge tamponade to treat atonic postpartum hemorrhage, they said.
“This device is being developed to offer a low-cost, easy-to-use product that is of similar or greater efficacy than the condom uterine balloon tamponade,” needs no electricity, and could be used in low-resource areas, they said.
A larger study comparing the sponge and condom uterine balloon tamponade is planned.
“Future studies will include a larger number of participants with quantitative blood loss assessment to determine the device’s effect in managing more patients with severe postpartum hemorrhage,” the investigators noted.
Rigorous research needed
“Uterine atony is too often disastrous, and new safe and effective treatments for it would be welcome,” Dwight J. Rouse, MD, associate editor of obstetrics for Obstetrics & Gynecology, wrote in an accompanying editorial.
The current balloon tamponade used to treat postpartum hemorrhage can be difficult to place and require ongoing monitoring, he said.
Although the mini-sponge device showed promise, the study was not randomized or controlled, thus lacking in evidence of effectiveness, said Dr. Rouse.
“We simply know that the participants had the devices placed and most of them stopped bleeding,” he said.
The mechanism of action is sound, but more research is needed, especially in light of other examples of new technologies, such as adhesion barriers and negative pressure wound dressing systems after cesarean deliveries, that “made sense in the abstract but failed to improve outcomes when evaluated in proper randomized trials,” Dr. Rouse noted.
“Absent such trials, we will never really know the relative value of any device to treat uterine atony refractory to medical management,” he said.
Lead author Dr. Rodriguez disclosed that her institution received funding from OBSTETRX, which funded the study, as well as the National Institutes of Health and Merck. Dr. Rodriguez disclosed funding from Bayer, while Dr. Rouse had no financial conflicts to disclose.
SOURCE: Rodriguez MI et al. Obstet Gynecol. 2020 Oct 8. doi: 10.1097/AOG.0000000000004135.