Using the Alma System to treat severe bleeding after childbirth

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

This study is testing whether the Alma System can safely and effectively stop severe bleeding after childbirth in women who have experienced postpartum hemorrhage.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: ResQ Medical Ltd (Academic / other)
• Locations: 2 sites (Brooklyn, New York and 1 other locations)
• Trial ID: NCT06646653 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the feasibility of the Alma System in treating primary postpartum hemorrhage (PPH) in women. The study involves 10 subjects who have experienced PPH, focusing on the safety and effectiveness of the Alma System in rapidly reducing or stopping bleeding caused by uterine atony. Key objectives include assessing the absence of serious adverse events, potential damage to reproductive organs, and the system's ability to effectively contract the uterus and reduce blood loss. The trial is conducted under strict ethical oversight to ensure participant safety.

Who should consider this trial

Good fit: Ideal candidates are adult females who have experienced postpartum hemorrhage and have not responded to first-line treatments.

Not a fit: Patients who have lost excessive blood beyond the study's thresholds or those with certain blood coagulation disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective method for managing severe postpartum hemorrhage, potentially saving lives.

How similar studies have performed: While this approach is novel, similar interventions for managing postpartum hemorrhage have shown promise in other studies.

Eligibility criteria

1. Adult Female, 18 years of age or older at time of consent.
2. Able to understand and provide informed consent to participate in the study.
3. Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.
4. EBL, determined when investigator is ready to have the Alma peel pack opened:

   Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL
5. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

Note: Uterotonic administration may continue concomitantly with and post Alma use, as long as such use does not exceed the maximum dose of the drug 10.3.2 Exclusion Criteria

1. EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
2. Delivery at a gestational age \< 34 weeks.
3. For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma.
4. PPH that the investigator determines to require more aggressive treatment, including any of the following:

   1. hysterectomy;
   2. b-lynch suture;
   3. uterine artery embolization or ligation;
   4. hypogastric ligation.
5. Known uterine anomaly.
6. Ongoing intrauterine pregnancy.
7. Placenta abnormality including any of the following:

   1. known placenta accreta;
   2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);
   3. retained placenta without easy manual removal.
8. Known uterine rupture.
9. Unresolved uterine inversion.
10. Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma.
11. Current cervical cancer.
12. Current purulent infection of vagina, cervix, uterus.
13. Diagnosis of coagulopathy.

Where this trial is running

Brooklyn, New York and 1 other locations

• Maimonides Medical Center | Brooklyn, New York Hospital — Brooklyn, New York, United States (Not_yet_recruiting)
• Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)

Study contacts

• Study coordinator: Yael Corcos, RN

Conditions Postpartum Haemorrhage; PPH; Postpartum Hemorrhage; Alma System; postpartum hemorrhage; pph