First Real-World Observational Study of the JADA® System, a Medical Device to Control Postpartum Hemorrhage (PPH), Published in ACOG’s Obstetrics & Gynecology
- JADA System effectively controls postpartum uterine bleeding with a success rate of 92.5% in vaginal births and 83.7% in cesarean births.
- Lower blood loss prior to device insertion associated with lower severe maternal morbidity.
- None.
JADA Rapidly and Effectively Controlled Bleeding Due to PPH,1 Reinforcing Pivotal Study Results1
PPH is a Significant Cause of Maternal Morbidities in the
New Exploratory Post-Hoc Analysis Examined the Relationship Between Reported Severe Maternal Morbidity (SMM) Outcomes and Cumulative Blood Loss Prior to JADA Insertion1
“PPH is a potentially life-threatening obstetric emergency that can occur after childbirth and requires timely medical intervention.1,6 Appropriate management of abnormal postpartum uterine bleeding is critical to minimize the potential clinical consequences of PPH7 and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy,”1,8,9 said lead author Dena Goffman, M.D., a maternal-fetal 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
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.1 Treatment success was defined as bleeding control after insertion with no treatment escalation or bleeding recurrence.1 JADA achieved treatment success in both the vaginal (
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.1 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.2,10 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.1
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.1
Blood Loss Thresholds Prior to Device Insertion |
SMM Outcomes by Cumulative Blood Loss Prior to Device Insertion1 |
|||
any RBC transfusion
|
≥4 units of RBCs
|
ICU admission
|
Hysterectomy
|
|
≤999 mL |
|
|||
Vaginal (n=170) |
20 ( |
3 ( |
3 ( |
2 ( |
Cesarean (n=23) |
6 ( |
0 (0) |
1 ( |
0 (0) |
1,000-1999 mL |
|
|||
Vaginal (n=203) |
63 ( |
5 ( |
8 ( |
2 ( |
Cesarean (n=142) |
74 ( |
10 ( |
14 ( |
2 ( |
2,000–2999 mL |
|
|||
Vaginal (n=53) |
40 ( |
11 ( |
8 ( |
1 ( |
Cesarean (n=58) |
50 ( |
10 ( |
7 ( |
2 ( |
≥3,000 mL |
|
|||
Vaginal (n=5) |
5 ( |
5 ( |
3 ( |
2 ( |
Cesarean (n=15) |
15 ( |
8 ( |
7 ( |
3 ( |
ICU, intensive care unit, RBC, red blood cell; SMM, severe maternal morbidity.
“Severe maternal morbidity rates in the
Adverse events in RUBY were consistent with the pivotal study PEARLE (NCT02883673) and what would be expected when managing an obstetric emergency.1 Three serious adverse device events were deemed possibly related to the device or procedure [2 (
About RUBY
The RUBY study was an observational, post-market registry chart review conducted at 16 U.S. hospitals from October 2020 through March 2022.1 The study evaluated real-world use experience with JADA among 800 patients (n=530 vaginal, n=270 cesarean),1
The study successfully met its primary measure.1 Additionally, secondary outcome measures were met,1 including the following which expanded upon JADA clinical findings:
-
Time to bleeding control (available in
49% of patients) was achieved within five minutes in73.8% of vaginal births (n=178) and62.2% of cesarean births (n=94) after JADA insertion and within one minute for45.6% of the vaginal group (n=110) and34.4% (n=52) of the cesarean group.1 - Treatment duration was short from insertion to removal, known as in-dwelling time, with a median of 3.1 hours for vaginal births and 4.6 hours for cesarean.1
-
As blood loss volume prior to JADA insertion increased, so did rates of blood transfusion, and all women who lost ≥3,000 mL of blood prior to JADA insertion (
100% ) received a blood transfusion.1 Red blood cell transfusions of ≥4 units (a measure of severe maternal morbidity) were required for4.5% (n=24) of those with vaginal births and12.6% (n=34) of those with cesarean births.1
Blood loss volume was collected per participating institutions’ protocols and included a mix of estimated and quantitative reporting.1
About Postpartum Hemorrhage
Postpartum hemorrhage (PPH), or abnormal postpartum uterine bleeding,1 is one of the most common complications of birth1,13,14,15 and may result in potential emergency intervention, such as hysterectomy or red blood cell transfusion.2,13 In some cases, it may even result in maternal death.2,13 PPH causes 70,000 maternal deaths globally every year, and
PPH is severe blood loss following childbirth6 that can result in heart rate or blood pressure changes.17 PPH is typically treated with pharmacologic agents and a uterine balloon.2 Consequences of PPH can lead to extended time in the hospital, blood transfusions and more serious complications.18,19,20
About JADA®
JADA is designed to apply low-level vacuum to encourage physiologic (consistent with normal functioning) contraction of the uterus to provide control and treatment of abnormal uterine bleeding or hemorrhage after childbirth.1,3 JADA was first cleared by the FDA in August 2020 based on results from the pivotal PEARLE IDE Study.1,3 The study showed that JADA helped provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted with an acceptably demonstrated safety profile.1,7
Please refer to the JADA® System Instructions for Use for indications, warnings, precautions and contraindications at tinyurl.com/JADAIFU2.
About Organon
Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.
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1 Goffman D, Rood K. Real-world utilization of an intrauterine vacuum-induced hemorrhage-control device. Obstetrics & Gynecology. Online publication date September 14, 2023. Available from: https://journals.lww.com/greenjournal/fulltext/9900/real_world_utilization_of_an_intrauterine,.902.aspx
2 Postpartum Hemorrhage. www.acog.org. Published October 2017. https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2017/10/postpartum-hemorrhage. Accessed July 31, 2023.
3 D'
4 Corbetta-Rastelli CM, Friedman AM, Sobhani NC, Arditi B, Goffman D, Wen T. Postpartum hemorrhage trends and outcomes in
5 Creanga AA, Berg CJ, Ko JY, et. al. Maternal mortality and morbidity in
6 World Health Organisation. (2022). WHO postpartum haemorrhage (PPH) summit. https://www.who.int/publications/m/item/who-postpartum-haemorrhage-(pph)-summit
7 D’Alton M, Rood K, Simhan H, Goffman D. Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage. Expert Rev Med Devices. 2021;18:849–53. doi: 10.1080/17434440.2021.1962288
8 Severe Maternal Morbidity in
9 ACOG Obstetric Care Consensus number 5: severe maternal morbidity: screening and review. Obstet Gynecol. 2016;128(3):e54-e60. doi: 10.1097/AOG.0000000000001642
10 ACOG Safe Motherhood Initiative. Obstetric Hemorrhage Checklist. Accessed April 2023. smi-ob-hemorrhage-bundle-hemorrhage-checklist.pdf (acog.org)
11 Gill P, Patel A, Van Hook JW. Uterine atony. StatPearls. NCBI Bookshelf. Updated February 6, 2023. https://www.ncbi.nlm.nih.gov/books/NBK493238/. Accessed July 31, 2023.
12 RUBY Post-Market Registry on the JADA® System - Full text view - ClinicalTrials.gov. (n.d.). https://classic.clinicaltrials.gov/ct2/show/NCT04995887
13 Callaghan WM, Creanga AA, Kuklina EV. Severe maternal morbidity among delivery and postpartum hospitalizations in
14 Pregnancy mortality surveillance system. Centers for Disease Control and Prevention. March 23, 2023. Accessed July 31, 2023. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm
15 Ahmadzia HK, Grotegut CA, James AH. A national update on rates of postpartum haemorrhage and related interventions. Blood Transfus. 2020;18:247-53. Doi: 10.2450/2020.0319-19.
16 Wolfson C, Qian J, Chin P, et al. Findings from severe maternal morbidity surveillance and review in
17 Borovac-Pinheiro A, Cecatti JG, de Carvalho Pacagnella R. Ability of shock index and heart rate to predict the percentage of body blood volume lost after vaginal delivery as an indicator of severity: results from a prospective cohort study. J Glob Health. 2019;9(2):020432. doi.10.7189/jogh.09.020432.
18 Evidence-based practice center systematic review protocol project title: management of postpartum hemorrhage. Agency for Healthcare Research and Quality. June 11, 2014. Accessed July 31, 2023. https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/hemorrhage-postpartum_research-protocol.pdf
19 McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011;9(8):1441-1451. doi: 10.1111/j.1538-7836.2011.04398.x
20 Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a
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