RUBY Post-Market Registry on the Jada® System

Postpartum Hemorrhage Clinical Trial

— RUBY  

Official title:

RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995887
• Other study ID #: CIP-05 v1.0
• Secondary ID: Protocol No. PPH
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2022
• Source: Alydia Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.

Description:

The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 809
• Est. completion date: April 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Use of the Jada System (inserted into the patient and connected to vacuum).

NOTE: There is no Exclusion Criteria in this protocol.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Device:
• Jada® System
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.

Locations

Country	Name	City	State
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Ohio Health	Gahanna	Ohio
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Loma Linda University	Loma Linda	California
United States	Allina (Abbott Northwestern)	Minneapolis	Minnesota
United States	Charleston Birth Place	Mount Pleasant	South Carolina
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Oshsner Baptist	New Orleans	Louisiana
United States	Mount Sinai	New York	New York
United States	Nyph/Cumc	New York	New York
United States	ChristianaCare	Newark	Delaware
United States	UPMC - Magee Women's Hospital	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Alydia Health

Country where clinical trial is conducted

United States, 

References & Publications (15)

American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. — View Citation

Andersen HF, Hopkins MP. Chapter 80: postpartum hemorrhage. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004.

Baskett TF. A flux of the reds: evolution of active management of the third stage of labour. J R Soc Med. 2000 Sep;93(9):489-93. — View Citation

Callaghan WM, Kuklina EV, Berg CJ. Trends in postpartum hemorrhage: United States, 1994-2006. Am J Obstet Gynecol. 2010 Apr;202(4):353.e1-6. doi: 10.1016/j.ajog.2010.01.011. — View Citation

D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138. — View Citation

Della Torre M, Kilpatrick SJ, Hibbard JU, Simonson L, Scott S, Koch A, Schy D, Geller SE. Assessing preventability for obstetric hemorrhage. Am J Perinatol. 2011 Dec;28(10):753-60. doi: 10.1055/s-0031-1280856. Epub 2011 Jun 22. — View Citation

Goffman D, Ananth CV, Fleischer A, D'Alton M, Lavery JA, Smiley R, Zielinski K, Chazotte C; Safe Motherhood Initiative Obstetric Hemorrhage Work Group. The New York State Safe Motherhood Initiative: Early Impact of Obstetric Hemorrhage Bundle Implementation. Am J Perinatol. 2019 Nov;36(13):1344-1350. doi: 10.1055/s-0038-1676976. Epub 2019 Jan 4. — View Citation

Gülmezoglu AM, Lawrie TA, Hezelgrave N, Oladapo OT, Souza JP, Gielen M, Lawn JE, Bahl R, Althabe F, Colaci D, Hofmeyr GJ. Interventions to Reduce Maternal and Newborn Morbidity and Mortality. In: Black RE, Laxminarayan R, Temmerman M, Walker N, editors. Reproductive, Maternal, Newborn, and Child Health: Disease Control Priorities, Third Edition (Volume 2). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2016 Apr 5. Chapter 7. — View Citation

Lyon DS. Chapter 90: postpartum care. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004.

Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS; National Partnership for Maternal Safety; Council on Patient Safety in Women's Health Care. National Partnership for Maternal Safety: Consensus Bundle on Obstetric Hemorrhage. Obstet Gynecol. 2015 Jul;126(1):155-62. doi: 10.1097/AOG.0000000000000869. Erratum in: Obstet Gynecol. 2015 Nov;126(5):1111. Obstet Gynecol. 2019 Jun;133(6):1288. — View Citation

Mulic-Lutvica A, Bekuretsion M, Bakos O, Axelsson O. Ultrasonic evaluation of the uterus and uterine cavity after normal, vaginal delivery. Ultrasound Obstet Gynecol. 2001 Nov;18(5):491-8. Erratum in: Ultrasound Obstet Gynecol. 2008 Aug;29(8):1215. — View Citation

Purwosunu Y, Sarkoen W, Arulkumaran S, Segnitz J. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol. 2016 Jul;128(1):33-36. doi: 10.1097/AOG.0000000000001473. — View Citation

Rossen J, Okland I, Nilsen OB, Eggebø TM. Is there an increase of postpartum hemorrhage, and is severe hemorrhage associated with more frequent use of obstetric interventions? Acta Obstet Gynecol Scand. 2010 Oct;89(10):1248-55. doi: 10.3109/00016349.2010.514324. — View Citation

Shields LE, Smalarz K, Reffigee L, Mugg S, Burdumy TJ, Propst M. Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products. Am J Obstet Gynecol. 2011 Oct;205(4):368.e1-8. doi: 10.1016/j.ajog.2011.06.084. Epub 2011 Jun 29. — View Citation

Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Cessation of PPH	Proportion of patients with atony-related abnormal postpartum uterine bleeding or PPH successfully treated with the Jada System. Treatment success is defined as the avoidance of escalated non-surgical or surgical intervention to control abnormal postpartum uterine bleeding or PPH after the Jada System was used.; Note: Concomitant treatment with uterotonics or uterine compression sutures does not constitute escalation (i.e., failure). However, if the Jada treatment was aborted to instead administer treatment with compression sutures for ongoing bleeding, then the event does meet the escalation (i.e., failure) definition.	24 hours
Primary	Safety: device-related Adverse Events	Rates of procedure- and device-related adverse events.	24 hours through time of discharge.
Secondary	Rate of non-surgical or surgical procedures other than Jada	Rate of non-surgical or surgical procedures other than Jada for atony-related bleeding after Jada was used	24 hours
Secondary	Transfusion rates	Rate of blood transfusions	24 hours through time of discharge.
Secondary	In-dwelling time of Jada during treatment	In-dwelling time (i.e., insertion of Jada to removal of Jada)	24 hours
Secondary	Time spent in care settings	Time spent in care settings (e.g., L&D, OR, Delivery Room, Postpartum Room, ICU, Other) from Jada treatment through discharge	24 hours through time of discharge.
Secondary	Length of stay	Length of stay (LOS) from delivery to discharge	24 hours through time of discharge.