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

NCT06166771 | Unknown

• 2 other identifiers: CD-01-001-PRResQ Medical IL # 516181633
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Hemorrhage \(PPH\); Postpartum Hemorrhage \(Primary\); PPH

Keywords

alma, pph, post partum hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• User Feedback on Placement of Alma

  When removing the Alma System at the end of the procedure

• User Feedback on Connection to Vacuum

  When removing the Alma System at the end of the procedure

• Rate of Uterine Contraction

  When removing the Alma System at the end of the procedure

• Time to Visible Reduction in Blood Flow

  When removing the Alma System at the end of the procedure

Study Arms (1)

Woman who developed PPH after vaginal birth and first line therapies have been attempted and failed

EXPERIMENTAL

Group which Alma treatment was applied

Device: Alma system

Interventions

Alma system DEVICE

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.

Also known as: Vacuum induced heamorrhage control, Obstetric-gynecologic specialized manual instrument

Woman who developed PPH after vaginal birth and first line therapies have been attempted and failed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Female, 18 years of age or older at time of consent.
• Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
• 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.
• Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

You may not qualify if:

• Subjects who do not provide informed consent to participate in the clinical investigation.
• Subjects who deliver at a uterus size \< 34 weeks.
• Subjects who have lost greater than 1000 ml of blood.
• Subjects who have abnormal PT, PTT and INR
• Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
• 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.
• 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);

Sponsors & Collaborators

• ResQ Medical Ltd: lead

Study Sites (1)

UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES

Nairobi, Kenya

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage; Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Omondi Ogutu, Prof. M.D.

CONTACT

254-722-510215; oomogutu@gmail.com

Alfred Osoti, Prof. M.D.

CONTACT

254-733-886664; alfredos@uonbi.ac.ke

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 12, 2023
• Study Start: September 9, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)