Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage (NCT06166771) | Clinical Trial Compass
UnknownNot Applicable
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 range18 Years
SexFEMALE
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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 \> = 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.
✕. Subjects who deliver at a uterus size \< 34 weeks.
✕. Subjects who have lost greater than 1000 ml of blood.
✕. Subjects who have abnormal PT, PTT and INR
✕
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