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

Completed · Not applicable

Conditions studied: Postpartum Hemorrhage

In brief

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.

Key facts

Study ID

NCT02883673

Run by

Alydia Health

People needed

107

Starts

2017-09-17

Expected to finish

2020-03-25

Last updated by the study team

2022-08-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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