RecruitingNot ApplicableNCT06646653
Feasibility Clinical Study of the Alma System in Treating Primary Postpartum Hemorrhage
Sponsor
ResQ Medical Ltd
Enrollment
10 participants
Start Date
Apr 14, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Feasibility clinical study of the Alma System in treating primary postpartum hemorrhage (PPH).
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- 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 placenta with failure to obtain contraction and/or Subjects who have lost blood post-vaginal delivery \> = 500 ml and lost blood post-cesarian delivery \> = 1000 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.
Exclusion Criteria18
- 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 \> 1000 ml of blood for vaginal birth and \> 2000 ml for caesarian delivery.
- 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.
Interventions
DEVICEAlma 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06646653