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.
Device: Jada System
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02883673
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT02883673
United States (16)
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Chicago, Illinois, United States, 60611
Indianapolis, Indiana, United States, 46202
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
New York Presbyterian Queens
Flushing, New York, United States, 11355
New York, New York, United States, 10032
Cleveland, Ohio, United States, 44109
The Ohio State University
Columbus, Ohio, United States, 43210
Danville, Pennsylvania, United States, 17822
UPMC - Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
University of Texas
Galveston, Texas, United States, 77555
University of Texas Health Science
Houston, Texas, United States, 77030
University of Utah
Salt Lake City, Utah, United States, 84132
University of Virginia
Charlottesville, Virginia, United States, 22908
St. Mary's Hospital
Madison, Wisconsin, United States, 53715
View full eligibility
Tris trial is registered with FDA with number: NCT02883673. The sponsor of the trial is Alydia Health and it is looking for 107 volunteers for the current phase.
Official trial title: Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
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