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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883673
Recruitment Status : Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Alydia Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Device: Jada System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Actual Study Start Date : September 17, 2017
Actual Primary Completion Date : January 26, 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Efficacy: 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

  2. Safety: Incidence, severity and seriousness of device-related Adverse Events [ Time Frame: 6 weeks ]
    Incidence, severity and seriousness of device-related Adverse Events will be documented during the course of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883673


Locations
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United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
New York Presbyterian Queens
Flushing, New York, United States, 11355
Nyph/Cumc
New York, New York, United States, 10032
United States, Ohio
MetroHealth Case Western
Cleveland, Ohio, United States, 44109
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
UPMC - Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
UT Health Science Center, McGovern School of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Alydia Health
Investigators
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Principal Investigator: Mary D'Alton, MD Columbia University
Publications:
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Responsible Party: Alydia Health
ClinicalTrials.gov Identifier: NCT02883673    
Other Study ID Numbers: CIP-01 v2.6
PPH-02 ( Other Identifier: Alydia Health )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Alydia Health:
Postpartum Hemorrhage
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage