Actively Recruiting
EVE TRIAL , ALMA SYSTAM
Led by ResQ Medical Ltd · Updated on 2026-03-30
50
Participants Needed
2
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening complication that requires immediate medical treatment. What you need to know: * Signing this form does not mean you will have an emergency postpartum bleeding. * We will only include you in the study IF abnormal bleeding happens after your birth. * If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol. * The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding. Treatment Schedule - Recruitment \& Consenting * Screening and enrolment. * Treatment of PPH with Alma system. * Alma Survey * Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital). * 6-week postpartum follow-up examination.
CONDITIONS
Official Title
EVE TRIAL , ALMA SYSTAM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female aged 18 years or older at time of consent
- Able to understand and provide informed consent
- Diagnosed with abnormal postpartum uterine bleeding or hemorrhage with suspected uterine atony within 24 hours after vaginal or cesarean delivery
- Estimated blood loss between 500 and 1500 milliliters for vaginal delivery or between 1000 and 1500 milliliters for cesarean delivery
- Failed first-line treatments of uterotonics and uterine massage to stop bleeding
You will not qualify if you...
- Estimated blood loss greater than 1500 milliliters
- Delivery at a gestational age less than 34 weeks
- Cervix less than 3 cm dilated before Alma system use in cesarean births
- Postpartum hemorrhage requiring more aggressive treatments (hysterectomy, b-lynch suture, uterine artery embolization or ligation, hypogastric ligation)
- Known uterine anomaly
- Ongoing intrauterine pregnancy
- Placenta abnormalities including placenta accreta, retained placenta with risk factors, or retained placenta without easy manual removal
- Known uterine rupture
- Unresolved uterine inversion
- Previous intrauterine balloon therapy, uterine packing, or other negative pressure tamponade treatments for this PPH before Alma system use
- Current cervical cancer
- Current purulent infection of vagina, cervix, or uterus
- Diagnosis of coagulopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Maimonides Medical Center | Brooklyn, New York Hospital
Brooklyn, New York, United States, 11219
Not Yet Recruiting
2
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
Research Team
Y
Yael Corcos, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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