Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage ("Alma system")

Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section.

In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth.

The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Study Overview

• Status: Recruiting
• Conditions: PPH; Postpartum Hemorrhage \(PPH\); Postpartum Hemorrhage \(Primary\)
• Intervention / Treatment: Device: Alma system

Detailed Description

A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the Alma System.

Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage.

The main questions are:

1. Rate of device related SAEs up to six weeks following device treatment.
2. Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure.
3. Rate of occurrence of uterine inversion of folding during or immediately after device procedure.

Main tasks for participants:

• sign the informed Consent form and enrolment
• In case of PPH, treatment with Alma
• Participate in 2 follow-up visits After the treatment- 1st upon discharge and 2nd after 6 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omondi Ogutu, Prof. M.D.; Phone Number: 254-722-510215; Email: oomogutu@gmail.com
• Study Contact Backup: Name: Alfred Osoti, Prof. M.D.; Phone Number: 254-733-886664; Email: alfredos@uonbi.ac.ke

Study Locations

• Kenya
  • Nairobi, Kenya
    • Recruiting
    • UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES
    • Contact: Omondi Ogutu, Prof. M.D.; Phone Number: 254-722-510215; Email: oomogutu@gmail.com
    • Contact: Alfred Osoti, Prof. M.D.; Email: alfredos@uonbi.ac.ke
    • Contact: Alfred Osoti, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Woman who developed PPH after vaginal birth and first line therapies have been attempted and failed; Group which Alma treatment was applied

Device: Alma system; Subjects diagnosed with 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.; Other Names: Vacuum induced heamorrhage control; Obstetric-gynecologic specialized manual instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Related SAEs	Rate of device related SAEs up to six weeks following device treatment.	6 weeks
Rate of Damage to Cervix, Uterus or Vagina	Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure	When removing the Alma System at the end of the procedure
Rate of Occurrence of Uterine Inversion or Folding	Rate of occurrence of uterine inversion or folding during or immediately after device procedure	When removing the Alma System at the end of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Feedback on Placement of Alma	Rate of positive user feedback on device placement trans-vaginally	When removing the Alma System at the end of the procedure
User Feedback on Connection to Vacuum	Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure	When removing the Alma System at the end of the procedure
Rate of Uterine Contraction	Rate of uterine contraction to a level that reduces or stops blood flow	When removing the Alma System at the end of the procedure
Time to Visible Reduction in Blood Flow	Time from insertion and start of negative pressure to visible reduction in blood flow	When removing the Alma System at the end of the procedure

Collaborators and Investigators

• Sponsor: ResQ Medical Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 20, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: alma, pph, post partum hemorrhage
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Hemorrhage
• Other Study ID Numbers: CD-01-001-PR; ResQ Medical IL # 516181633 (Other Identifier: ResQ Medical Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No