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Validating a New Method to Assess Estimated Blood Loss in the Obstetric Population

NCT03404375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2021-02-25

Study results available
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Summary

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation. Traditionally, the surgeon performing the cesarean section would estimate the blood loss by visually assessing the blood collected in the surgical drape and counting the number of lap sponges used thru out the procedure. The investigators would like to study and validate an FDA approved device called the gauss Triton device used to estimate blood loss during scheduled cesarean sections.

Conditions

  • Pregnancy Complications

Interventions

DEVICE

Gauss Triton system

The Triton system (Gauss Surgical, Inc., Palo Alto, CA) is a novel mobile monitoring platform that combines mobile computing with Gauss Feature Extraction Technology (FET) to directly assess Hb mass (mHb) absorbed by surgical sponges from an image. The device is an iPad like imaging device that will assess blood loss via imaging of the surgical sponges used in the surgery. The device will be used to calculate blood loss on every patient enrolled in the study.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Fawzi Saoud, MD · UTMB-Galveston

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-11-01
Completion
2018-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03404375 on ClinicalTrials.gov