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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:September 17, 2017
End Date:November 2019
Contact:Kathryn D Wine, MPH
Email:kathryn@alydiahealth.com
Phone:415-990-4104

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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

The purpose of this study is to evaluate the safety and effectiveness of the InPress Device
in the control and reduction of primary postpartum hemorrhage.

This IDE study is designed to evaluate the effectiveness and safety of the InPress Device to
treat primary PPH. The study is literature controlled.

Inclusion Criteria:

1. Adult Female, 18 years of age or older at time of consent.

2. Able to understand and provide informed consent to participate in the study.

3. Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section
delivery.

4. EBL, to be determined when investigator is ready to have InPress Device peel pack
opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500
ml EBL.

5. Failed first-line intervention of uterotonics and uterine massage/bimanual compression
to stop bleeding. Note: Pitocin administration may continue concomitant with and post
InPress Device use.

Exclusion Criteria:

1. EBL > 1500 ml, to be determined when investigator is ready to have the InPress Device
peel pack opened.

2. Delivery at a gestational age < 34 weeks.

3. For C-sections: Cervix < 3 cm dilated before C-section.

4. 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.

5. Known uterine anomaly.

6. Ongoing intrauterine pregnancy.

7. 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.

8. Known uterine rupture.

9. Unresolved uterine inversion.

10. Subject has undergone intrauterine balloon therapy or uterine packing for tamponade
treatment of this PPH prior to use of the InPress Device.

11. Current cervical cancer.

12. Current purulent infection of the vagina, cervix, uterus.

13. Diagnosis of coagulopathy.
We found this trial at
7
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Akila Subramaniam, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Maged Costantine, MD
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Marcela Smid, MD
Phone: 801-213-2845
University of Utah Research is a major component in the life of the U benefiting...
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Flushing, New York 11355
Principal Investigator: Armin Razavi, MD
Phone: 718-670-1707
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700 South Park Street
Madison, Wisconsin 53715
Principal Investigator: Paul Boeder, MD
Phone: 608-283-7320
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New Brunswick, New Jersey 08903
Principal Investigator: Christina Duzyj, MD
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New Brunswick, NJ
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161 Fort Washington Avenue
New York, New York 10032
Principal Investigator: Dena Goffman, MD
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New York, NY
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