MedDataX Logo

Trial Outcomes & Findings for Continuous Non-Invasive Measurement of Hemoglobin During Parturition (NCT NCT03150043)

NCT ID: NCT03150043

Last Updated: 2021-02-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

1 day post partum

Results posted on

2021-02-24

Participant Flow

Participant milestones

Participant milestones
Measure
All Participants
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. Masimo Rainbow Pulse CO-oximeter: Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery
Overall Study
STARTED
65
Overall Study
COMPLETED
65
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Non-Invasive Measurement of Hemoglobin During Parturition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=65 Participants
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. Masimo Rainbow Pulse CO-oximeter: Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery
Age, Continuous
26.9 years
n=5 Participants
Sex: Female, Male
Female
65 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
40 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
11 Participants
n=5 Participants
Race (NIH/OMB)
White
50 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
65 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 day post partum

Population: This value was compared to post operative day 1 hemoglobin from a complete blood count testing. We used Pearson correlation analysis. range of values from +1 to -1. A value of 0 indicates that there is no association between the two variables. A value greater than 0 indicates a positive association;

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

Outcome measures

Outcome measures
Measure
End of Case Non-invasive Hemogblobin
n=19 Participants
This value was obtained from the non-invasive device at the end of the case (hemoglobin g/dL).
Pearson Correlation Coefficient for Hemoglobin Measurements
0.6 Correlation Coeficient

SECONDARY outcome

Timeframe: 0-5 days post partum

Population: Among all participant, the ncount of participants that received blood transfusion.

The rates in percentage of patients that received transfusion of packed red blood cells.

Outcome measures

Outcome measures
Measure
End of Case Non-invasive Hemogblobin
n=65 Participants
This value was obtained from the non-invasive device at the end of the case (hemoglobin g/dL).
Number of Participants Who Required Blood Transfusion
65 Participants

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Jelliffe

UTMB

Phone: 2146635394

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place