Using the Alma System to treat severe bleeding after childbirth

Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage

This study is testing a new device called the Alma System to see if it can help women who are experiencing severe bleeding after childbirth when other treatments haven't worked.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: ResQ Medical Ltd (other)
• Locations: 1 site (Nairobi)
• Trial ID: NCT06166771 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the safety and effectiveness of the Alma System, a new medical device designed to control abnormal postpartum bleeding in women who have recently given birth. It focuses on women who have experienced postpartum hemorrhage (PPH) and have not responded to standard treatments. Participants will receive treatment with the Alma System and will be monitored for any adverse effects and the device's effectiveness in stopping the bleeding. Follow-up visits will occur at discharge and six weeks post-treatment to assess outcomes.

Who should consider this trial

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

Not a fit: Patients who have lost more than 1000 ml of blood or have other complications such as retained placenta or uterine lacerations may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly reduce the risks associated with postpartum hemorrhage, improving maternal health outcomes.

How similar studies have performed: While this approach is novel, similar studies on device-based interventions for postpartum hemorrhage have shown promise in improving outcomes.

Eligibility criteria

Inclusion Criteria:

1. Adult Female, 18 years of age or older at time of consent.
2. Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
3. Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum \> = 500 ml and according to the Investigator's judgment, require an intervention.
4. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

Exclusion Criteria:

1. Subjects who do not provide informed consent to participate in the clinical investigation.
2. Subjects who deliver at a uterus size \< 34 weeks.
3. Subjects who have lost greater than 1000 ml of blood.
4. Subjects who have abnormal PT, PTT and INR
5. Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
6. PPH that the investigator determines to require more aggressive treatment, including any of the following:

   * Hysterectomy;
   * B-lynch suture;
   * Uterine artery embolization or ligation;
   * Hypogastric ligation.
   * Known uterine anomaly.
   * Ongoing intrauterine pregnancy.
7. Placental abnormality including any of the following:

   * Known placenta accreta;
   * Retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior c-section and placenta previa);
   * Retained placenta without easy manual removal.
8. Known uterine rupture.
9. Unresolved uterine inversion.

Where this trial is running

Nairobi

• UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES — Nairobi, Kenya (RECRUITING)

Study contacts

• Study coordinator: Omondi Ogutu, Prof. M.D.

Conditions: Postpartum Hemorrhage \, PPH, alma, pph, post partum hemorrhage