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
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 (P<0.001)1
Users said they would recommend the Jada System
Confirmed among 99 investigators, in most cases using Jada for the first time.1,2
In nearly every case, investigators rated Jada easy to use1
Confirmed among 99 investigators, in most cases using Jada for the first time.
Bleeding Was Controlled Within 3 Minutes (Median)1
1 Minute (median time)
Uterine Collapse Observed
3 Minutes (median time)
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.
- American Indian/
Alaskan Native: 1%
- Refused: 2%
- Other: 8%
- Asian: 8%
- Black: 24%
- White: 57%
- Hispanic: 15%
- Non-Hispanic: 82%
- Other: 1%
- Refused: 2%
Postpartum hemorrhage at previous delivery
Preeclampsia (this pregnancy)
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