Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage
NCT ID: NCT06166771
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-09-09
2025-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Woman who developed PPH after vaginal birth and first line therapies have been attempted and failed
Group which Alma treatment was applied
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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ResQ Medical Ltd
OTHER
Responsible Party
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Locations
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UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES
Nairobi, , Kenya
Countries
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Central Contacts
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Facility Contacts
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Alfred Osoti, Prof.
Role: backup
Other Identifiers
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ResQ Medical IL # 516181633
Identifier Type: OTHER
Identifier Source: secondary_id
CD-01-001-PR
Identifier Type: -
Identifier Source: org_study_id
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