Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

November 29, 2024 updated by: Joseph Chappelle, Stony Brook University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

women who are scheduled for an elective repeat or primary cesarean delivery. We will exclude women at high-risk for hemorrhage, thalassemia major, sickle cell disease, or women with hypertensive disorders

Description

Inclusion Criteria:

  • Women undergoing scheduled cesarean delivery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women Undergoing Scheduled Cesarean Delivery
We will be recruiting women who are scheduled for an elective repeat or primary cesarean delivery.
Device: Masimo Rainbow Sensor
Non-Invasive Hemoglobin Measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in Hemoglobin over time
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Joseph Chappelle, MD, Stony Brook University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2014

Primary Completion (Actual)

October 30, 2016

Study Completion (Actual)

October 30, 2016

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimated)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 613231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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