Intrauterine device controls bleeding for vaginal, cesarean births in real-world settings

Key takeaways:

• Treatment success for the JADA system was high for both vaginal and cesarean births.
• Overall, 2.8% of women in the vaginal and 4.1% of women in the cesarean birth groups had bleeding recurrence.

Use of an intrauterine vacuum-induced hemorrhage control device led to rapid and effective bleeding control for vaginal and cesarean births, according to real-world study results published in Obstetrics & Gynecology.

The device (JADA system, Organon) was cleared by the FDA for managing abnormal postpartum uterine bleeding in August 2020.

“Postpartum hemorrhage remains a leading cause of preventable severe maternal morbidity and mortality. We need additional tools to treat this obstetric emergency,” Dena Goffman, MD, vice chair for quality and patient safety and Ellen Jacobson Levine and Eugene Jacobson Professor of Women’s Health in Obstetrics and Gynecology at Columbia University Irving Medical Center, told Healio. “The JADA system is a recently FDA-cleared intrauterine vacuum-induced hemorrhage control device, which was safe and effective in the previously published pivotal trial.”

Goffman and colleagues evaluated data from the RUBY study, an observational, multicenter, post-market registry medical record review of 16 U.S. centers from October 2020 to March 2022. The study enrolled 800 women (mean age, 30.3 years) who were treated with the device. Researchers assessed the real-world effectiveness and safety of the device for postpartum hemorrhage management.

The primary outcome was treatment success, defined as bleeding control after insertion of the device with no treatment escalation or bleeding recurrence. Secondary outcomes included blood loss, time to insertion, time from insertion to removal, bleeding recurrence and time to bleeding control.

Overall, 530 women had vaginal births and 270 had cesarean births, and 94.3% had uterine atony.

At device insertion, median total blood loss was 1,050 mL in vaginal births, with 25% of women having blood loss more than 1,500 mL before insertion. For cesarean births, median blood loss was 1,600 mL, with 25% of women having blood loss more than 2,000 mL before insertion. Treatment success for the device was 92.5% for vaginal births and 83.7% for cesarean births. Treatment success rates were highest in isolated uterine atony cases for vaginal (95.8%) and cesarean (88.2%) births.

The median time from insertion to removal for vaginal births was 3.1 hours, with 2.8% of women having bleeding recurrence after removal. Cesarean births had a median time of 4.6 hours from insertion to removal, with 4.1% of women having bleeding recurrence after removal. In addition, the median time from delivery to device insertion was 31 minutes for vaginal births and 108 minutes for cesarean births.

Regarding adverse events, 14 serious adverse events were reported by 2.5% of women in the vaginal birth group and 22 were reported by 7.8% of women in the cesarean birth group. In total, three serious adverse events were identified as possibly related to the device or procedure.

Researchers noted that no uterine perforations or deaths were reported.

“First and foremost, we need additional information to develop an evidence-based understanding of where the device belongs in postpartum hemorrhage management algorithms. To accomplish this, we should strive for comparative effectiveness research to understand how JADA compares with existing therapies,” Goffman said. “We also need research on how to achieve value in care of birthing and postpartum patients with hemorrhage. We need clear metrics that define quality of postpartum hemorrhage care and additional information on the costs associated with hemorrhage associated treatments.”

For more information:

Dena Goffman, MD, can be reached at dg2018@cumc.columbia.edu.