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Clinical Trials/NCT02275507
NCT02275507
Completed
Not Applicable

Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

Stony Brook University1 site in 1 country50 target enrollmentOctober 15, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complications of Pregnancy, Childbirth and the Puerperium
Sponsor
Stony Brook University
Enrollment
50
Locations
1
Primary Endpoint
Decrease in Hemoglobin over time
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to determine the normal hemoglobin curve during cesarean delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to detect life-threatening bleeding earlier.

Detailed Description

Acute and life threatening blood loss is the most common cause of morbidity and mortality for pregnancy women in the US. To date, the only means we have of monitoring the amount of blood loss during a delivery is by the physician estimating the amount. This has been shown to not be very accurate and leads to confusion on when and how much a women should be transfused during a hemorrhage. New devices have been developed over the last few years to monitor blood levels in a accurate and non-invasive fashion. We aim here to use a non-invasive blood monitoring system to evaluate normal blood loss in women undergoing scheduled cesarean delivery. We hope that this will allow us to create a baseline that can be used in subsequent studies to identify women who are losing more blood than normal so that we may intervene faster and avoid unnecessary morbidity.

Registry
clinicaltrials.gov
Start Date
October 15, 2014
End Date
October 30, 2016
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Chappelle

Assistant Professor

Stony Brook University

Eligibility Criteria

Inclusion Criteria

  • Women undergoing scheduled cesarean delivery

Exclusion Criteria

  • Blood disorders (i.e. thalassemia, sickle cell), hypertensive disorders, obstetric risk factors for hemorrhage

Outcomes

Primary Outcomes

Decrease in Hemoglobin over time

Time Frame: 24 hours

Study Sites (1)

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