RUBY Post-Market Registry on the Jada® System

NCT04995887 | Completed FDA Device

• 2 other identifiers: CIP-05 v1.0Protocol No. PPH-05
• Study Type: observational
• Target: 809
• Locations: 1 country
• Sites: 16

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.

Conditions

Postpartum Hemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Safety: device-related Adverse Events

  Rates of procedure- and device-related adverse events.

  24 hours through time of discharge.

Secondary Outcomes (5)

• Rate of non-surgical or surgical procedures other than Jada

  24 hours

• Transfusion rates

  24 hours through time of discharge.

• In-dwelling time of Jada during treatment

  24 hours

• Time spent in care settings

  24 hours through time of discharge.

• Length of stay

  24 hours through time of discharge.

Study Arms (4)

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

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

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

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

Interventions

Jada® System DEVICE

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.

Also known as: Vacuum-induced Hemorrhage Control, Obstetric-Gynecologic Specialized Manual Instrument

C-Section Delivery with EBL < 1500 mL; C-Section Delivery with EBL ≥ 1500 mL; Vaginal Delivery with EBL < 1000 mL; Vaginal Delivery with EBL ≥ 1000 mL

Eligibility Criteria

• Gender Eligibility Details: Conditions treated occur only in females of childbearing age (i.e., postpartum hemorrhage or abnormal postpartum uterine bleeding).
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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."

You may qualify if:

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

Sponsors & Collaborators

• Alydia Health: lead

Study Sites (16)

Loma Linda University

Loma Linda, California, 92354, United States

Location

ChristianaCare

Newark, Delaware, 19718, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Oshsner Baptist

New Orleans, Louisiana, 70115, United States

Location

Allina (Abbott Northwestern)

Minneapolis, Minnesota, 55409, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Nyph/Cumc

New York, New York, 10032, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Ohio Health

Gahanna, Ohio, 43230, United States

Location

UPMC - Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Charleston Birth Place

Mt. Pleasant, South Carolina, 29464, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25302, United States

Location

Related Publications (17)

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  PMID: 27227224 BACKGROUND

• 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.

  PMID: 20350642 BACKGROUND

• 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.

  PMID: 11844171 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11089490 BACKGROUND

• 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.

  PMID: 26241269 BACKGROUND

• 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.

  PMID: 30609429 BACKGROUND

• 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.

  PMID: 22083059 BACKGROUND

• 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.

  PMID: 20809871 BACKGROUND

• 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.

  PMID: 21698554 BACKGROUND

• 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.

  PMID: 17012482 BACKGROUND

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

  PMID: 21173639 BACKGROUND

• 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.

  PMID: 27275795 BACKGROUND

• 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.

  PMID: 32909970 BACKGROUND

• Rood KM, Bianco A, Biggio JR, Smid MC, Simhan HN, Li J, Yong C, Carney PI, Croft DJ, Goffman D. Real-world use of a vacuum-induced hemorrhage-control device in births <34 weeks gestational age. J Matern Fetal Neonatal Med. 2025 Dec;38(1):2451658. doi: 10.1080/14767058.2025.2451658. Epub 2025 Feb 9.

  PMID: 39924257 DERIVED

• Goffman D, Rood KM, Bianco A, Biggio JR, Dietz P, Drake K, Heilman E, Hopkins M, De Four Jones M, Katz T, Martin C, Prasad M, Smid MC, Wine KD, Ryan R, Yong C, Carney PI, Simhan HN. Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device. Obstet Gynecol. 2023 Nov 1;142(5):1006-1016. doi: 10.1097/AOG.0000000000005366. Epub 2023 Sep 13.

  PMID: 37713322 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dena Goffman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 9, 2021
• Study Start: October 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

US (16)