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

August 18, 2022 updated by: Alydia Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

809

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University
    • Delaware
      • Newark, Delaware, United States, 19718
        • ChristianaCare
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Oshsner Baptist
    • Minnesota
      • Minneapolis, Minnesota, United States, 55409
        • Allina (Abbott Northwestern)
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai
      • New York, New York, United States, 10032
        • Nyph/Cumc
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Gahanna, Ohio, United States, 43230
        • Ohio Health
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC - Magee Women's Hospital
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Charleston Birth Place
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • Charleston Area Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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."

Description

Inclusion Criteria:

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

NOTE: There is no Exclusion Criteria in this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
Safety: device-related Adverse Events
Time Frame: 24 hours through time of discharge.
Rates of procedure- and device-related adverse events.
24 hours through time of discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
Transfusion rates
Time Frame: 24 hours through time of discharge.
Rate of blood transfusions
24 hours through time of discharge.
In-dwelling time of Jada during treatment
Time Frame: 24 hours
In-dwelling time (i.e., insertion of Jada to removal of Jada)
24 hours
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
24 hours through time of discharge.
Length of stay
Time Frame: 24 hours through time of discharge.
Length of stay (LOS) from delivery to discharge
24 hours through time of discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alydia Health

Investigators

  • Principal Investigator: Dena Goffman, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-05 v1.0
  • Protocol No. PPH-05 (Other Identifier: Alydia Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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