First real-world observational study of the JADA®System, a medical device to control postpartum hemorrhage (PPH), published in ACOG’s Obstetrics & Gynecology

Organon, a global healthcare company focused on improving women’s health, today announced that Obstetrics & Gynecology (“The Green Journal”), the peer-reviewed journal of the American College of Obstetrics and Gynecology (ACOG), published the results of the RUBY study (NCT04995887) which reached its primary effectiveness outcome of successfully treating abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH) with the JADA® System. 

JADA is an intrauterine vacuum-induced hemorrhage control device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

PPH is a potentially life-threatening obstetric emergency that can occur after childbirth and requires timely medical intervention. Appropriate management of abnormal postpartum uterine bleeding is critical to minimize 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 hemorrhage control device is an important tool for PPH management.

Dena Goffman, M.D., Maternal-Fetal Medicine Subspecialist, and Professor and Vice Chair for Quality and Patient Safety, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center

Study design and results

The RUBY (Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage with the JADA® System) observational, post-market, registry review study assessed records of 800 patients across 16 U.S. 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. JADA achieved treatment success in both the vaginal (92.5%) and cesarean birth (83.7%) groups, regardless of the cause of the abnormal postpartum uterine bleeding.

The primary study outcomes were presented at Society for Maternal-Fetal Medicine’s (SMFM) 43rd Annual Pregnancy Meeting in February 2023. Secondary outcome measures, including time to bleeding control, in-dwelling time, total blood loss and red blood cell transfusions, were also presented.

New post-hoc analysis supports appropriate control of blood loss

In an exploratory post-hoc analysis, red blood cell (RBC) transfusion and severe maternal morbidities (SMM) outcomes were summarized by blood loss at time of device insertion. ACOG defines PPH as cumulative blood loss of ≥1,000 mL and recommends women are carefully and thoroughly evaluated once they have lost 500 mL post-vaginal delivery and 1,000 mL post-cesarean delivery. In RUBY, median post-delivery blood loss prior to device insertion was 1,050 mL in the vaginal group and 1,600 mL in the cesarean group.

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.

Blood Loss Thresholds Prior to Device Insertion

SMM Outcomes by Cumulative Blood Loss Prior to Device Insertion 

any RBC transfusion
n (%)

≥4 units of RBCs
n (%)

ICU admission
n (%)

Hysterectomy
n (%)

≤999 mL

 

Vaginal (n=170)

20 (12%)

3 (2%)

3 (2%)

2 (1%)

Cesarean (n=23)

6 (26%)

0 (0)

1 (4%)

0 (0)

1,000-1999 mL

 

Vaginal (n=203)

63 (31%)

5 (3%)

8 (4%)

2 (1%)

Cesarean (n=142)

74 (52%)

10 (7%)

14 (10%)

2 (1%)

2,000–2999 mL

 

Vaginal (n=53)

40 (76%)

11 (21%)

8 (15%)

1 (2%)

Cesarean (n=58)

50 (86%)

10 (17%)

7 (12%)

2 (3%)

≥3,000 mL

 

Vaginal (n=5)

5 (100%)

5 (100%)

3 (60%)

2 (40%)

Cesarean (n=15)

15 (100%)

8 (53%)

7 (47%)

3 (20%)

ICU, intensive care unit, RBC, red blood cell; SMM, severe maternal morbidity.

Severe maternal morbidity rates in the U.S. are rising, and PPH is recognized 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.

Patricia Carney, M.D., FACOG, Organon Medical Affairs

Adverse events in RUBY were consistent with the pivotal study PEARLE (NCT02883673) and what would be expected when managing an obstetric emergency. Three serious adverse device events were deemed possibly related to the device or procedure [2 (0.4%) vaginal, 1 (0.4%) cesarean], all of which resolved with treatment.

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