Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04277962 · ClinicalTrials.gov registry record · NA
Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
A NA study, sponsored by The University of Texas Medical Branch, Galveston.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT04277962: Clinical Trial NA study, sponsored by The University of Texas Medical Branch, Galveston.
NCT04277962 is a NA study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04277962, a NA study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. If patients agree to participate, a CBC (complete blood count) will be obtained via venous puncture routine in our facility as part of the admission labs which will be around 10 cc of blood. The device will be used during the delivery in laboring room. The device will be used to assess QBL (quantitative blood loss) by the research staff only and results/ QBL assessment will be masked to the clinical team. Unmasking will only occur following study completion with purpose to perform data analysis. Patient management will be according to the clinical team without the knowledge of the QBL. All patients undergo a CBC postpartum as part of post-partum evaluation, this will also be performed by venipuncture where 10 cc of blood will be collected. The drop in Hgb (hemoglobin) between the pre and post partum CBCs will be calculated for each patient. The post-partum CBC will be collected approximately 24-30 hours from delivery as standard in our unit. The blood will be collected from each patient by the nursing staff who are experienced in withdrawing blood. Patients will be divided into quartiles of Hgb. Cases will be those patients whose Hgb is in the upper quartile, while controls will be those patients whose Hgb is in the lower 3 quartiles. We will be comparing visual EBL (estimated blood loss) by standard clinical assessment versus the QBL result from the device between cases and controls. The Triton L\&D (labor and delivery) system which comprises of the device, software analysis and staff training will be supplied by the manufacturer free of charge. Research staff will be trained by the manufacturer. We will be offering our skills, fellows, midwifes and residents, who will be collecti
Interventions
- DEVICE Triton L and D system for estimation of blood loss at time of vaginal delivery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
Why NCT04277962 stopped before completion
NCT04277962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Triton L and D system for estimation of blood loss at time of vaginal delivery is the first listed.
NCT04277962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04277962 about?
NCT04277962 is a clinical study titled "Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial". This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. If patients...
What is the current status of trial NCT04277962?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2020-05-01. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04277962?
The interventions under investigation include: Triton L and D system for estimation of blood loss at time of vaginal delivery (DEVICE).
Who is sponsoring clinical trial NCT04277962?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04277962's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI