Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

Complications of Pregnancy, Childbirth and the Puerperium Clinical Trial

Official title:

Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275507
• Other study ID #: 613231
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2014
• Last updated: April 28, 2016
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: April 2016
• Source: Stony Brook University
• Contact: Joseph Chappelle, MD
• Phone: 631-444-27457
• Email: joseph.chappelle[@]stonybrook.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women undergoing scheduled cesarean delivery

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complications of Pregnancy, Childbirth and the Puerperium
• Pregnancy Complications

Intervention

Device:
• Masimo Rainbow Sensor
Non-Invasive Hemoglobin Measurement

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Hemoglobin over time		24 hours	No