RUBY Post-Market Registry on the Jada® System (RUBY)

• ClinicalTrials.gov Identifier: NCT04995887
• Recruitment Status: Completed
• First Posted: August 9, 2021
• Last Update Posted: August 22, 2022
• Sponsor: Alydia Health
• Information provided by (Responsible Party): Alydia Health

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Postpartum Hemorrhage	Device: Jada® System

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 809 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: March 31, 2022
• Actual Study Completion Date: April 30, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
C-Section Delivery with EBL ≥ 1500 mL; Patients with ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).	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.; Other Names: Vacuum-induced Hemorrhage Control; Obstetric-Gynecologic Specialized Manual Instrument
C-Section Delivery with EBL < 1500 mL; Patients with < 1500 mL EBL at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).	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.; Other Names: Vacuum-induced Hemorrhage Control; Obstetric-Gynecologic Specialized Manual Instrument
Vaginal Delivery with EBL ≥ 1000 mL; Patients with ≥ 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).	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.; Other Names: Vacuum-induced Hemorrhage Control; Obstetric-Gynecologic Specialized Manual Instrument
Vaginal Delivery with EBL < 1000 mL; Patients with < 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).	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.; Other Names: Vacuum-induced Hemorrhage Control; Obstetric-Gynecologic Specialized Manual Instrument

Outcome Measures

Primary Outcome Measures :

1. Efficacy: Cessation of PPH [ Time Frame: 24 hours ]

   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.

2. Safety: device-related Adverse Events [ Time Frame: 24 hours through time of discharge. ]
   Rates of procedure- and device-related adverse events.

Secondary Outcome Measures :

1. Rate of non-surgical or surgical procedures other than Jada [ Time Frame: 24 hours ]
   Rate of non-surgical or surgical procedures other than Jada for atony-related bleeding after Jada was used
2. Transfusion rates [ Time Frame: 24 hours through time of discharge. ]
   Rate of blood transfusions
3. In-dwelling time of Jada during treatment [ Time Frame: 24 hours ]
   In-dwelling time (i.e., insertion of Jada to removal of Jada)
4. Time spent in care settings [ Time Frame: 24 hours through time of discharge. ]
   Time spent in care settings (e.g., L&D, OR, Delivery Room, Postpartum Room, ICU, Other) from Jada treatment through discharge
5. Length of stay [ Time Frame: 24 hours through time of discharge. ]
   Length of stay (LOS) from delivery to discharge

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Conditions treated occur only in females of childbearing age (i.e., postpartum hemorrhage or abnormal postpartum uterine bleeding).
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients included are all identified through review of the medical charts as having received Jada treatment starting from the center's first commercial use of the Jada System. This chart review will be ongoing until the specified date or until a minimum of 100 patients are enrolled in each of the groups described below (whichever occurs first):

1. ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion (C-S)
2. < 1500 mL EBL at time of Jada insertion (C-S)
3. ≥ 1000 mL EBL at time of Jada insertion (vaginal)
4. < 1000 mL EBL at time of Jada insertion (vaginal)

Up to a maximum of 50 sites can be included in this registry. Each IRB approval constitutes a "site."

Criteria

Inclusion Criteria:

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

NOTE: There is no Exclusion Criteria in this protocol.

Contacts and Locations

Locations

United States, California

Loma Linda University

Loma Linda, California, United States, 92354

United States, Delaware

ChristianaCare

Newark, Delaware, United States, 19718

United States, Georgia

Northeast Georgia Medical Center

Gainesville, Georgia, United States, 30501

United States, Louisiana

Oshsner Baptist

New Orleans, Louisiana, United States, 70115

United States, Minnesota

Allina (Abbott Northwestern)

Minneapolis, Minnesota, United States, 55409

United States, New York

Long Island Jewish Medical Center

New Hyde Park, New York, United States, 11040

Mount Sinai

New York, New York, United States, 10029

Nyph/Cumc

New York, New York, United States, 10032

United States, Ohio

University Hospitals

Cleveland, Ohio, United States, 44106

Cleveland Clinic

Cleveland, Ohio, United States, 44195

The Ohio State University

Columbus, Ohio, United States, 43210

Ohio Health

Gahanna, Ohio, United States, 43230

United States, Pennsylvania

UPMC - Magee Women's Hospital

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Charleston Birth Place

Mount Pleasant, South Carolina, United States, 29464

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84132

United States, West Virginia

Charleston Area Medical Center

Charleston, West Virginia, United States, 25302

Sponsors and Collaborators

Alydia Health

Investigators

• Principal Investigator: Dena Goffman, MD; Columbia University

More Information

Publications:

Gulmezoglu 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK361904/

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.

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. doi: 10.1046/j.0960-7692.2001.00561.x. Erratum In: Ultrasound Obstet Gynecol. 2008 Aug;29(8):1215.

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

Lyon DS. Chapter 90: postpartum care. 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. doi: 10.1177/014107680009300913. No abstract available.

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.

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.

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.

Rossen J, Okland I, Nilsen OB, Eggebo 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.

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.

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. doi: 10.1097/00006250-200610000-00046.

Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.

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.

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.

• Responsible Party: Alydia Health
• ClinicalTrials.gov Identifier: NCT04995887
• Other Study ID Numbers: CIP-05 v1.0; Protocol No. PPH-05 ( Other Identifier: Alydia Health )
• First Posted: August 9, 2021
• Last Update Posted: August 22, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: It is not yet known if there will be a plan to make IPD available.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Alydia Health:

Vacuum-Induced Hemorrhage-Control (VHC); Jada; Postpartum Hemorrhage

Additional relevant MeSH terms:

Postpartum Hemorrhage; Hemorrhage; Pathologic Processes; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage