Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

Completed

• Conditions: Complications of Pregnancy, Childbirth and the Puerperium
• Interventions: Device: Masimo Rainbow Sensor

• Registration Number: NCT02275507
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Study Start: 2014-10-15
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-27
• Primary Completion: 2016-10-30
• Study Completion: 2016-10-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women Undergoing Scheduled Cesarean Delivery	Masimo Rainbow Sensor	We will be recruiting women who are scheduled for an elective repeat or primary cesarean delivery.

Primary Outcome Measures

Name	Time	Method
Decrease in Hemoglobin over time	24 hours

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States