EVE TRIAL , ALMA SYSTAM
Recruiting
Phase 3
Interventional Study
Postpartum Haemorrhage (PPH)
PPH
Postpartum Hemorrhage (Primary)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- ResQ Medical Ltd · Other
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About This Trial
abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening com…
Trial Locations
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Eligibility Criteria
1. Adult Female, 18 years of age or older at time of consent.
2. Able to understand and provide informed consent to participate in the study.
3. Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.
4. EBL, determine…
Contacts