The Evidence Is in
The JADA System was evaluated in a US clinical trial, the PEARLE study.
The PEARLE Study
The PEARLE study was a prospective, multi-center, pivotal, single-arm study designed to assess the safety and effectiveness of the JADA System in treating primary postpartum hemorrhage and abnormal postpartum uterine bleeding, and enrolled 107 subjects.1
The JADA System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Before using JADA, please read the contraindications, warnings, precautions, and other important information in the Instructions for Use.
At controlling postpartum uterine bleeding
In the PEARLE study, 94% of participants met the primary end point: bleeding was controlled successfully with JADA, and no further intervention was required.1
(n=100/106)
Users said they would recommend the JADA System
Highly recommended among surveyed clinical investigators, in most cases using JADA for the first time.1,2
(n=104/107)
In nearly every case, investigators rated JADA easy to use
Highly recommended among surveyed clinical investigators, in most cases using JADA for the first time.1,2
(n=105/107)
Bleeding Was Controlled Within 3 Minutes (Median)1
1 Minute (median time)
Uterine Collapse Observed
3 Minutes (median time)
Bleeding Controlled
Safety Profile2
There were no adverse events deemed definitely related to the device or the procedure and there was a low rate of possibly device-related adverse events.
- 5 possibly device-related adverse events were rated as “moderate” and no event was rated as “severe.”
- 3 moderate events were cases of endometritis, which is a known risk of long labor, vaginal exam, and postpartum hemorrhage.
Demographics and Obstetric History of PEARLE Subjects1 (N=107)
JADA was studied in a diverse patient population with representation of high-risk subgroups.
Demographics*
Race
- American Indian/
Alaskan Native: 1% - Refused: 2%
- Other: 8%
- Asian: 8%
- Black: 24%
- White: 57%
Ethnicity
- Hispanic: 15%
- Non-Hispanic: 82%
- Other: 1%
- Refused: 2%
*Race and ethnicity categories were collected according to National Institutes of Health standards. “Other” as a category was included by patient self-report.
Patient Characteristics
Postpartum hemorrhage at previous delivery*
Baseline anemia†
Preeclampsia (this pregnancy)
Twins
*Includes participants with a previous delivery in the denominator.
†Baseline and chronic anemia are defined by site-specific protocol and diagnosis.
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