Status:
COMPLETED
Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
Lead Sponsor:
Alydia Health
Conditions:
Post Partum Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).
Detailed Description
10 subjects in first in woman trial with ethics committee oversight. Women who developed postpartum hemorrhage were treated with the InPress Device. The intent of treatment was to quickly reduce or st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04364386
Start Date
July 27 2014
End Date
April 1 2015
Last Update
September 19 2024
Active Locations (2)
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1
Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
2
RSIA Budi Kemuliaan Hospital
Jakarta, Indonesia