Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial

NCT04277962 | Terminated Results FDA Device

• 1 other identifier: 19-0147
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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 collecting data and we will be performing the data analysis. Results will be available to the manufacturer after results are completed. The results of this study will be presented in conferences or published in a peer-review journal. Demographic information will be obtained from the electronic medical record. The data will be kept on a password secured University of Texas Medical Branch (UTMB) computer. An encrypted USB flash drive will be used to transfer data. The data will be identified and linked to the patient using the medical record number. During data analysis, all patient identifiers will be deleted.

Conditions

Post Partum Hemorrhage; Blood Loss; Vaginal Bleeding; Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

• Differences in Blood Loss Between Cases and Controls Using Clinical Estimate (Visual EBL) Versus Device Assessment (QBL).

  At time of vaginal delivery

Study Arms (1)

Patients having vaginal delivery

EXPERIMENTAL

EBL will be estimated visually vs quantitatively at time of vaginal delivery.

Device: Triton L and D system for estimation of blood loss at time of vaginal delivery

Interventions

Triton L and D system for estimation of blood loss at time of vaginal delivery DEVICE

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.

Patients having vaginal delivery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Criteria for inclusion of subjects: Pregnant women between the ages of 18-50. Plan of care is vaginal delivery. Criteria for exclusion of subjects: Incarcerated patients. Patient unwilling or unable to provide consent. Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians). Placenta previa or other known placental anomalies. Any contraindications to vaginal delivery. Enrolled in another trial that may affect outcome.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

UTMB Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Antonio Saad Director of Clinical Research Division
• Organization: University of Texas Medical Branch Galveston

afsaad@utmb.edu

409-772-0982

Study Officials

• Antonio Saad, MD

  UTMB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: May 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 18, 2023
• Results First Posted: June 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)