Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage (PEARLE)

August 18, 2022 updated by: Alydia Health

Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

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
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical School
    • New York
      • Flushing, New York, United States, 11355
        • New York Presbyterian Queens
      • New York, New York, United States, 10032
        • Nyph/Cumc
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Case Western
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC - Magee Women's Hospital
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • UT Health Science Center, McGovern School of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Adult Female, 18 years of age or older at time of consent.
  2. Able to understand and provide informed consent to participate in the study.
  3. Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
  4. EBL, to be determined when investigator is ready to have Jada peel pack opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500 ml EBL.
  5. Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post Jada use.

Exclusion Criteria:

  1. EBL > 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
  2. Delivery at a gestational age < 34 weeks.
  3. For C-sections: Cervix < 3 cm dilated before Jada use.
  4. PPH that the investigator determines to require more aggressive treatment, including any of the following: a) hysterectomy, b) b-lynch suture, c) uterine artery embolization or ligation, d) hypogastric ligation.
  5. Known uterine anomaly.
  6. Ongoing intrauterine pregnancy.
  7. Placenta abnormality including any of the following: a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal.
  8. Known uterine rupture.
  9. Unresolved uterine inversion.
  10. Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
  11. Current cervical cancer.
  12. Current purulent infection of the vagina, cervix, uterus.
  13. Diagnosis of coagulopathy.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.
Device: Jada System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging
Time Frame: 24 hrs
Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System per the Instructions for Use
24 hrs
Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants
Time Frame: 6 weeks
Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study.
6 weeks

Collaborators and Investigators

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

Sponsor

Alydia Health

Investigators

  • Principal Investigator: Mary D'Alton, 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)

September 17, 2017

Primary Completion (Actual)

January 26, 2020

Study Completion (Actual)

March 25, 2020

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

August 30, 2016

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-01 v2.6
  • PPH-02 (Other Identifier: Alydia Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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