Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) in Patients Undergoing Elective Cesarean Delivery

Completed

• Conditions: Postpartum Hemorrhage

• Registration Number: NCT01108471
• Lead Sponsor: Stanford University

Brief Summary

We aim to assess a new pulse oximeter which measures continuous hemoglobin concentration (SpHb) in healthy patients undergoing elective Cesarean delivery (CS). This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate. We will compare measurements of SpHb with estimated blood loss during the perioperative period, and laboratory measurements of hemoglobin at set time intervals during the perioperative and postoperative periods (to evaluate the accuracy of this device's ability to measure continuous SpHb).

Detailed Description

We hope that this pulse oximeter will provide important new information (SpHb) about hemoglobin measurement in patients undergoing elective CS, who may often experience significant blood loss and postpartum anemia in the perioperative period. The measurement of perioperative blood loss is often inaccurate, and formal measurements of hemoglobin levels are often associated with time delays, especially in the setting of ongoing acute blood loss. We hope that this device will provide accurate continuous data of hemoglobin in this patient population, which may prove to be a significant advance in patient monitoring in this patient population. Probes for SpHb measurement will be provided by Masimo Corporation.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

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

Inclusion Criteria

1. Healthy term (> 37 weeks gestation)
2. ASA 1 and 2 pregnant patients undergoing elective uncomplicated Cesarean delivery under neuraxial anesthesia
3. Age 18-40 yrs

Read More

Exclusion Criteria

1. Patients with abnormal Hemoglobin disorders.
2. Patients with hyperbilirubinemia.
3. Patients who are smokers.
4. Patients with peripheral vascular disease or conditions affecting vascularity of the digits.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total perioperative blood loss	Measured at the end of surgery (time frame cannto be specificied prior to study but estimated to be 60-90 mins)	The total estimated blood loss will be assessed at the end of the surgical period. This period is estimated to be 60-90 mins. We will record the time duration of surgery for all patients in the study.
maternal SpHb	SpHb measurements will be measured at the following timepoints:prior to surgery,continuously during the intraoperative period; within 10 minutes of completion of surgery; at 4hr, 24hr, and 48 hr following completion of surgery
maternal venous hemoglobin measurements	Maternal venous hemoglobin measurements will be performed at the following timepoints: prior to surgery, within 10 minutes of completion of surgery, 24 hr following completion of surgery

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States