FDA-Approved Device Significantly Cuts Postpartum Bleeding

September 25, 2023

A low-suction intrauterine device achieved rapid and effective bleeding control in most mothers experiencing postpartum hemorrhage (PPH) following both vaginal and caesarean deliveries in a post-market registry review study.

The results, published in the journal Obstetrics and Gynecology, support the use of the device as an important new tool for halting PPH, a condition that causes 12% of maternal deaths in the United States (2017–19). PPH is the most common cause (2.7%) of severe maternal morbidity (SMM) in the United States, which continues to rise.

The device works by creating a low-level vacuum that clears blood from the uterus and stimulates uterine muscles to contract and compress blood vessels. Uterine atony, as this is called, is the most common cause of PPH. Any uterine atony occurred in 93.8% and 95.2% in vaginal and cesarean births respectively.

The analysis comprised data from 800 individuals — representing 530 vaginal and 270 cesarean births — treated with the device. Treatment success — defined as bleeding control not requiring treatment escalation or bleeding recurrence after initial bleeding control and device removal — was achieved in 92.5% of vaginal births and in 83.7% of cesarean births.

“Our findings show that the device is an important new tool in managing postpartum bleeding,” said Dena Goffman, MD, in a press statement. Goffman is a professor of obstetrics and gynecology at Columbia University Vagelos College of Physicians and Surgeons and senior study author.

“We had previously shown that the device worked well with patients who were experiencing relatively minor bleeding, so it's really reassuring to see that the device worked almost as well among a wider range of patients and when used by many different doctors.”

The median total blood loss up to device insertion was 1,050 milliliters (mL) in vaginal births with 1 in 4 individuals losing more than 1,500 mL of blood. The median total loss was 1,600 mL in cesarean births with 1 in 4 individuals losing more than 2,000 mL. The device was in place for a median of 3.1 hours and 4.6 hours, respectively.

Time-to-bleeding-control was not available for all patients (49% of cases). However, definitive control of bleeding was achieved within 5 minutes for nearly three-quarters (73.8%) of vaginal births and 62.2% of cesarean births. Red blood cell transfusion was given in 29.2% of vaginal and 60.7% of vaginal and cesarean births respectively.

In terms of severe adverse events, 14 were reported in 13 individuals with vaginal births, and 22 were reported among 21 individuals with cesarean delivery. Three were considered to be possibly related to the device or procedure.