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 :
Completed
First Posted : August 30, 2016
Results First Posted : April 12, 2022
Last Update Posted : August 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postpartum Hemorrhage | Device: Jada System | Not Applicable |
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 |
Actual Study Completion Date : | March 25, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.
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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. |
- 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
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult Female, 18 years of age or older at time of consent.
- Able to understand and provide informed consent to participate in the study.
- Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
- 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.
- 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:
- EBL > 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
- Delivery at a gestational age < 34 weeks.
- For C-sections: Cervix < 3 cm dilated before Jada use.
- 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.
- Known uterine anomaly.
- Ongoing intrauterine pregnancy.
- 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.
- Known uterine rupture.
- Unresolved uterine inversion.
- Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
- Current cervical cancer.
- Current purulent infection of the vagina, cervix, uterus.
- Diagnosis of coagulopathy.
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
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 |
Principal Investigator: | Mary D'Alton, MD | Columbia University |
Documents provided by Alydia Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Results First Posted: | April 12, 2022 |
Last Update Posted: | August 22, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Postpartum Hemorrhage |
Postpartum Hemorrhage Hemorrhage Pathologic Processes Obstetric Labor Complications Pregnancy Complications |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Puerperal Disorders Uterine Hemorrhage |