Organon unveils study of medical device for postpartum haemorrhage control

The women’s health company Organon has announced the first observational study of its medical device for postpartum haemorrhage control.

The company has said that the Obstetrics & Gynecology journal published the results of the RUBY study which reached its primary effectiveness outcome of treating abnormal postpartum uterine bleeding and postpartum haemorrhage (PPH) with Organon’s JADA System.

JADA is an intrauterine vacuum-induced haemorrhage control device intended to provide control and treatment of abnormal PPH, a severe vaginal bleeding after childbirth that can occur within a day of giving birth or up to 12 weeks postpartum.

“PPH is a potentially life-threatening obstetric emergency that can occur after childbirth and requires timely medical intervention,” explained lead author Dena Goffman, a maternal-foetal medicine subspecialist, and professor and vice chair for quality and patient safety in the Department of Obstetrics and Gynecology at Columbia University Irving Medical Center in New York.

“Appropriate management of abnormal postpartum uterine bleeding is critical to minimise the potential clinical consequences of PPH and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy.

“The new study, which included a larger population than the pivotal trial, showed how the device is being used outside of a controlled clinical trial environment.

“The results indicate that the intrauterine vacuum-induced haemorrhage control device is an important tool for PPH management.”

The study assessed records of 800 patients across 16 US hospitals from October 2020 through March 2022 and evaluated JADA treatment of abnormal postpartum uterine bleeding and PPH in “real-world” settings.

Treatment success was defined as bleeding control after insertion with no treatment escalation or bleeding recurrence.

According to Organon, JADA achieved treatment success in both the vaginal (92.5 per cent) and cesarean birth (83.7 per cent) groups, regardless of the cause of the abnormal PPH.

When reviewing patient cases that received standard PPH interventions plus the JADA System, lower blood loss prior to device insertion was associated with lower severe maternal morbidity.

Patricia Carney, Organon director of medical affairs, said: “Severe maternal morbidity rates in the US are rising, and PPH is recognised as a major cause of some of these morbidities.

“While severe maternal morbidities occurred even at lower levels of blood loss in this study, higher rates of morbidity were associated with higher levels of blood loss prior to JADA treatment in conjunction with other interventions that may have been used.

“These data shed light on the importance of appropriate control of blood loss, and it’s encouraging that the RUBY study reinforced the JADA pivotal study results in a real-world setting.”

Organon said adverse events in RUBY were consistent with the study PEARLE and what would be expected when managing an obstetric emergency.

Three serious adverse device events were deemed possibly related to the device or procedure, all of which resolved with treatment, the company added.