Alma System for Postpartum Hemorrhage
(EVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Alma System to control severe bleeding after childbirth, known as postpartum hemorrhage (PPH). The goal is to determine if this device can stop the bleeding when usual treatments fail. The trial targets women who experience abnormal bleeding after giving birth and haven't responded to initial treatments like medication and uterine massage. Participants will receive monitoring throughout their hospital stay and a follow-up check six weeks later. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for PPH.
What prior data suggests that the Alma System is safe for treating postpartum hemorrhage?
Research has shown that the Alma System is promising for treating postpartum hemorrhage (PPH), which involves heavy bleeding after childbirth. Previous studies examined its safety and effectiveness, finding that the system—a soft silicone device placed in the uterus—is comfortable for patients. Importantly, no serious side effects have been linked to the Alma System, suggesting it is safe. Used only when other treatments fail, the Alma System offers a quick and easy way to manage dangerous bleeding after childbirth.12345
Why do researchers think this study treatment might be promising for postpartum hemorrhage?
The Alma System is unique because it offers a new approach to managing postpartum hemorrhage (PPH) when first-line interventions, like medications and manual techniques, have failed. Unlike traditional treatments that primarily focus on pharmacological solutions or surgical procedures, the Alma System is a device-based intervention. Researchers are excited about this treatment due to its potential to provide a rapid, non-invasive solution that can be applied directly where needed, potentially reducing the need for more invasive procedures like surgery. This could mean quicker stabilization for mothers experiencing severe bleeding after childbirth, preserving their health and well-being.
What evidence suggests that the Alma System is effective for postpartum hemorrhage?
Research has shown that the Alma System, which participants in this trial will receive, could help treat postpartum hemorrhage (PPH), or heavy bleeding after childbirth. Studies have found that this device can induce uterine contractions, helping to reduce or stop the bleeding. This is crucial because excessive bleeding can be very dangerous. The system consists of soft silicone and is placed inside the uterus to function. Early results suggest it might reduce the need for additional surgery. This could represent a significant advancement for those facing this serious issue.12346
Who Is on the Research Team?
Scott Chudnoff, MD
Principal Investigator
Maimonides Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Treatment of abnormal bleeding and postpartum hemorrhage (PPH) with the Alma system if initial treatments fail
Post Treatment Follow-up
Follow-up examination after removal of the Alma system before discharge from the hospital
6-Week Postpartum Follow-up
Final study follow-up assessment at routine 6-week postpartum check-up
What Are the Treatments Tested in This Trial?
Interventions
- Alma System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Woman who developed PPH after vaginal or caesarean delivery and first line interventions have been attempted and failed, and to which the Alma System was applied
Find a Clinic Near You
Who Is Running the Clinical Trial?
ResQ Medical Ltd
Lead Sponsor
Citations
Safety and Effectiveness of the Alma System in Treating ...
Subjects diagnosed with postpartum hemorrhage will receive the Alma System. This system comprises a soft silicone cylindrical device placed within the uterus.
2.
app.trialscreen.org
app.trialscreen.org/trials/safety-effectiveness-alma-system-treating-primary-postpartum-hemorrhage-trial-nct06166771Safety and Effectiveness of the Alma System in Treating ...
The main goals of this study are to evaluate the safety and effectiveness of the Alma System, a new medical device, in controlling and treating abnormal ...
Pharmacy and Poisons Board: Applications
Ability of Alma System to contract the uterus to a level that reduces or stops blood loss and avoids further non-surgical and surgical intervention. Evaluate ...
Randomized Trial of Early Detection and Treatment ...
Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, ...
Safety and Effectiveness of the Alma System in Treating ...
This study is focused on evaluating the safety and effectiveness of the Alma System in treating primary postpartum hemorrhage, a condition where women ...
Implementation of a Postpartum Hemorrhage Safety Bundle at ...
Examination of maternal outcomes at Grady found that PPH complicated 11% of deliveries and was responsible for 7.5% of preventable pregnancy-related deaths in a ...
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