N/A
Completed N=10
Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
Post Partum Hemorrhage
Source: ClinicalTrials.gov NCT04364386 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Number of Related SAE — 0 SAEs
Summary
Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Related SAE |
— | — |
| PRIMARY Number of Participants With Damage to Cervix, Uterus or Vagina |
— | — |
| PRIMARY Number of Participants With Uterine Inversion or Folding |
— | — |
| SECONDARY Number of Participants With User Feedback on Placement of InPress |
10 | — |
| SECONDARY Number of Participants With User Feedback on Connection to Vacuum |
9 | — |
| SECONDARY Time to Uterine Contraction |
1; 9 | — |
| SECONDARY Time |
152 | — |
Eligibility Criteria
Inclusion Criteria
- Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
- Female adult subjects (>18 years of age)
- 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.
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
- Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
Data sourced from ClinicalTrials.gov (NCT04364386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.