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

Not Applicable

Completed

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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Intervention	Jada System	Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.

Primary Outcome Measures

Name	Time	Method
Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging	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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (15): Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
UPMC - Magee Women's Hospital
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Pittsburgh, Pennsylvania, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
UT Health Science Center, McGovern School of Medicine
🇺🇸
Houston, Texas, United States
MetroHealth Case Western
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Cleveland, Ohio, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
Northwestern University
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Chicago, Illinois, United States
University of Alabama Birmingham
🇺🇸
Birmingham, Alabama, United States
MedStar Washington Hospital Center
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Washington, District of Columbia, United States
Rutgers Robert Wood Johnson Medical School
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New Brunswick, New Jersey, United States
Nyph/Cumc
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New York, New York, United States
New York Presbyterian Queens
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Flushing, New York, United States
University of Texas Medical Branch
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Galveston, Texas, United States
University of Utah
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Salt Lake City, Utah, United States