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

Study Overview
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Brief Summary
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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
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This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.

Official Title
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Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Device: Jada System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage. | Device: Jada System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Hemorrhage