RUBY: Intrauterine device successfully decreases postpartum uterine bleeding
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Key takeaways:
- The JADA system decreased abnormal postpartum uterine bleeding in vaginal and cesarean birth, regardless of cause.
- Lower blood loss before insertion of JADA was linked to lower severe maternal morbidity.
An intrauterine vacuum-induced hemorrhage control device successfully decreased abnormal postpartum uterine bleeding, according to results of the real-world RUBY study published in Obstetrics & Gynecology.
The intrauterine device, the JADA system (Organon), was previously found successful for managing postpartum hemorrhage.
“We knew from the pivotal study that JADA was effective in managing abnormal postpartum bleeding and hemorrhage,” Amy Taneja, MD, FACOG, director of medical affairs at Organon, told Healio. “Now we know that it works in real-world settings outside of a clinical trial environment. It works in vaginal and cesarean births and across various blood loss categories.”
Researchers conducted an exploratory post hoc analysis of RUBY, an observational, post-market registry review of 800 patient records across 16 hospitals in the U.S. from October 2020 to March 2022. Researchers evaluated the JADA system, an intrauterine vacuum-inducted hemorrhage control device, for the treatment of abnormal postpartum hemorrhage.
The primary outcome was treatment success defined as bleeding control after insertion with no treatment escalation or recurrent bleeding.
Researchers observed treatment success with the JADA system in both vaginal delivery (92.5%) and cesarean birth (83.7%) groups, regardless of abnormal postpartum uterine bleeding cause.
In the post hoc analysis, researchers summarized red blood cell transfusion and severe maternal morbidity outcomes by blood loss at the time of insertion. Median post-delivery blood loss before insertion of JADA was 1,050 mL among women in the vaginal delivery group and 1,600 mL among women in the cesarean birth group. Lower blood loss before device insertion was linked to lower severe maternal morbidity when researchers reviewed cases that received standard interventions plus the JADA system.
In addition, adverse outcomes observed in RUBY were consistent with what is expected when managing an obstetric emergency, according to the researchers. Researchers noted three serious adverse device events that were possibly related to the JADA system reported by 0.4% of the vaginal delivery group and 0.4% of the cesarean birth group. All adverse events resolved with treatment.
“RUBY is a large observational, real-world study of 800 cases, which is unusual for a device study, and underscores the importance of JADA as an important tool for managing postpartum hemorrhage,” Taneja said. “Women’s health has historically been underfunded, and we welcome and support all research in the area of postpartum hemorrhage as well as other maternal health issues.”