Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage (NCT06166771) | Clinical Trial Compass
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Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage
Kenya10 participantsStarted 2024-09-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \> = 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.
Exclusion criteria
. Subjects who do not provide informed consent to participate in the clinical investigation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Related SAEs
Timeframe: 6 weeks
2
Rate of Damage to Cervix, Uterus or Vagina
Timeframe: When removing the Alma System at the end of the procedure
3
Rate of Occurrence of Uterine Inversion or Folding
Timeframe: When removing the Alma System at the end of the procedure