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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
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.
University of Alabama Birmingham
Birmingham, Alabama, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging
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
Time frame: 24 hrs
Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants
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.
Time frame: 6 weeks
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Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
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Flushing, New York, United States
Nyph/Cumc
New York, New York, United States
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Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
...and 5 more locations