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

NCT03404375 | Completed Results FDA Device

• 1 other identifier: 17-0248
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

scheduled cesarean section; term pregnancy; estimated blood loss; postpartum hemorrhage

Outcome Measures

Primary Outcomes (2)

• Clinical Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment

  The investigators are looking at the difference between the EBL measured clinically and the EBL measured using the Gauss device

  48 hours

• Triton Device Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment

  The investigators are looking at the difference between the EBL measured clinically and the EBL measured using the Gauss device (Triton)

  48 hours

Secondary Outcomes (2)

• Transfusion Requirements

  48 hours

• Number of Participants With Post-partum Hemorrhage

  48 hours

Study Arms (1)

Term patients

OTHER

This study only has one arm: term pregnant patients scheduled for cesarean sections. The surgeon will clinically estimate blood loss and the research team will estimate blood loss using the Gauss Triton system. This will be done on all 242 patients.

Device: Gauss Triton system

Interventions

Gauss Triton system DEVICE

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.

Term patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Term pregnant patients scheduled for cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between the ages of 18-50
• Scheduled cesarean delivery

You may not qualify if:

• 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
• Enrolled in another trial that may affect outcome.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Saoud F, Stone A, Nutter A, Hankins GD, Saade GR, Saad AF. Validation of a new method to assess estimated blood loss in the obstetric population undergoing cesarean delivery. Am J Obstet Gynecol. 2019 Sep;221(3):267.e1-267.e6. doi: 10.1016/j.ajog.2019.06.022. Epub 2019 Jun 20.

  PMID: 31229429 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Antonio Saad
• Organization: UTMB Galveston

afsaad@utmb.edu

4097721571

Study Officials

• Fawzi Saoud, MD

  UTMB-Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: December 8, 2017
• First Posted: January 19, 2018
• Study Start: March 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-01

Locations

US (1)