Trial Outcomes & Findings for Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial (NCT NCT04277962)
NCT ID: NCT04277962
Last Updated: 2023-06-18
Results Overview
TERMINATED
NA
11 participants
At time of vaginal delivery
2023-06-18
Participant Flow
The study was terminated early due to the Sponsor decided not to pursue because of COVID 19 delays. The 11 participants that consented did not start the study nor was any data collected.
Participant milestones
| Measure |
Patients Having Vaginal Delivery
EBL will be estimated visually vs quantitatively at time of vaginal delivery.
Triton L and D system for estimation of blood loss at time of vaginal delivery: The Triton L\&D system (Gauss Surgical, Inc., Menlo Park, CA) is an FDA-cleared mobile application on a tablet computer (iPad) that facilitates quantification of blood loss (QBL) by providing an easy to use process and user interface. Dry weights of all potential blood containing substrates are built-in to the device allowing batch weighing with automatic subtraction of dry weights. There is also a V-drape simulator accounting for collected fluids with automatic subtraction of a measured amount of amniotic fluid.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At time of vaginal deliveryPopulation: The study was terminated early due to the Sponsor decided not to pursue because of COVID 19 delays. The 11 participants that consented did not start the study nor was any data collected.
Outcome measures
Outcome data not reported
Adverse Events
Patients Having Vaginal Delivery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Antonio Saad Director of Clinical Research Division
University of Texas Medical Branch Galveston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place