RecruitingPhase 3NCT06646653

EVE TRIAL , ALMA SYSTAM

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Alma System in Treating Abnormal Postpartum utErine Bleeding or Hemorrhage

Sponsor

ResQ Medical Ltd

Enrollment

50 participants

Start Date

Jan 11, 2026

Study Type

INTERVENTIONAL

Conditions

Postpartum Haemorrhage (PPH)PPH Postpartum Hemorrhage (Primary)

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the Alma System, a device designed to control severe postpartum hemorrhage (heavy bleeding after childbirth) caused by a uterus that fails to contract properly — a condition called uterine atony — after first-line medications have not stopped the bleeding. **You may be eligible if...** - You are 18 years or older - You gave birth vaginally and lost 500 mL or more of blood, OR had a cesarean section and lost 1,000 mL or more - Your uterus has not contracted for at least 10 minutes after delivery of the placenta - Standard first-line treatments (uterotonic medications and uterine massage) have not worked **You may NOT be eligible if...** - Your bleeding is caused by something other than uterine atony (e.g., retained placenta, lacerations, uterine rupture) - You delivered at less than 34 weeks of pregnancy - You have already lost more than 1,000 mL (vaginal birth) or 2,000 mL (cesarean) of blood - You have abnormal blood clotting tests - The investigator determines more aggressive treatments (such as hysterectomy) are needed immediately Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAlma System

Subjects diagnosed with abnormal bleeding or postpartum hemorrhage will receive the Alma System. This system comprises a soft silicone cylindrical device placed within the uterus. Gentle suction is applied, prompting the uterus to contract and reduce in size. This contraction compresses the blood vessels, halting the bleeding.