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

Study Overview
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Brief Summary
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Prospective, non-randomized, feasibility pilot study Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur immediately 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. Prospective, non-randomized, feasibility pilot study The purpose of this study, clinical trial, is to obtain information on the safety and effectiveness of the investigational new medical device - Alma System,. Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage. The main questions are: Rate of device related SAE up to six weeks following device treatment. Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure. 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 visit followup After the treatment- 1st upon discharge and 2nd after 8 weeks.

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

Conditions
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PPH, Postpartum Hemorrhage \(PPH\), Postpartum Hemorrhage \(Primary\)

Intervention / Treatment
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* Device: Alma system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 less than or equal to 500 ml and according to the Investigators judgment, require an intervention. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Exclusion Criteria: Subjects who do not provide informed consent to participate in the clinical investigation. Subjects who deliver at a uterus size less than 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); Retained placenta without easy manual removal. Known uterine rupture. Unresolved uterine inversion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Woman who developed PPH after vaginal birth and first line therapies have been attempted and faile<br>Group which Alma treatment was applied | Device: Alma system<br>* 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.<br>* Other names: Obstetric-gynecologic specialized manual instrument;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, rate of participants with cessation of uterine hemorrhaging | Managing postpartum hemorrhage refers to preventing the need for any non-surgical, secondary, or surgical intervention to control uterine bleeding subsequent to employing the Alma System as directed in the Instructions for Use. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence, severity, and seriousness of device-related adverse events experienced by participants, assessing safety. | The study will document the occurrence (frequency or number of participants), severity, and seriousness of device-related Adverse Events experienced by participants throughout the duration of the research. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alma, pph, post partum hemorrhage