Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

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: Unknown
• Conditions: Complications of Pregnancy, Childbirth and the Puerperium
• Intervention / Treatment: Device: Masimo Rainbow Sensor

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 (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Joseph Chappelle, MD; Phone Number: 631-444-27457; Email: joseph.chappelle@stonybrook.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Joseph Chappelle, MD; Phone Number: 631-444-2757; Email: joseph.chappelle@stonybrook.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

How is the study designed?

Number of groups / cohorts

1

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	24 hours

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Butwick A, Hilton G, Carvalho B. Non-invasive haemoglobin measurement in patients undergoing elective Caesarean section. Br J Anaesth. 2012 Feb;108(2):271-7. doi: 10.1093/bja/aer373. Epub 2011 Nov 23.
• Chamos C, Vele L, Hamilton M, Cecconi M. Less invasive methods of advanced hemodynamic monitoring: principles, devices, and their role in the perioperative hemodynamic optimization. Perioper Med (Lond). 2013 Sep 17;2(1):19. doi: 10.1186/2047-0525-2-19.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: 613231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED