Continuous Non-Invasive Measurement of Hemoglobin During Parturition

NCT03150043 | Completed Results DMC FDA Device

• 1 other identifier: 17-0087
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

A non-invasive hemoglobin monitor will be used during cesarean delivery and the values obtained will be compared to values obtained from traditional blood draw.

Conditions

Hemorrhage; Cesarean Section

Keywords

Hemoglobin; Cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Pearson Correlation Coefficient for Hemoglobin Measurements

  Pearson Correlation Coefficient for hemoglobin measurements (Difference in Hemoglobin blood counts in g/dL between preop and post operative levels) obtained from blood draw to those obtained from the monitor

  1 day post partum

Secondary Outcomes (1)

• Number of Participants Who Required Blood Transfusion

  0-5 days post partum

Study Arms (1)

All Participants

OTHER

All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.

Device: Masimo Rainbow Pulse CO-oximeter

Interventions

Masimo Rainbow Pulse CO-oximeter DEVICE

Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery

All Participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women undergoing primary cesarean delivery after failed induction of labor, or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean)
• Pregnant women between the ages of 18-50

You may not qualify if:

• Patient who are not pregnant
• Patients unwilling or unable to provide consent
• Patients under the age of 18
• Patients who are incarcerated

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Katherine Jelliffe
• Organization: UTMB

katherine.emilie@gmail.com

2146635394

Study Officials

• Katherine H Jelliffe, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Antonio F Saad, MD

  University of Texas

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Since every patient will have the device placed during delivery, there will be no masking. However, the actual values obtained from the monitor will be masked.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients who agree to participate in the study will have the non-invasive hemoglobin monitor placed on their finger during delivery. The values obtained from the non invasive monitor will be masked to the clinicians during delivery. No medical decision making will be based on values obtained from the non-invasive monitor. After the patient leaves the recovery room, values obtained from the monitor will be compared to those obtained via blood draw. Patients will be separated into quartiles based on drop in hemoglobin (between pre-op and post-op day 1) and hemoglobin values obtained from the monitor will be compared between the quartiles.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 11, 2017
• Study Start: May 10, 2017
• Primary Completion: May 9, 2018
• Study Completion: May 9, 2018
• Last Updated: February 24, 2021
• Results First Posted: February 24, 2021

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)