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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01108471
Enrollment
50
Registered
2010-04-22
Start date
2010-04-30
Completion date
2011-03-31
Last updated
2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

cesarean section; hemoglobin; postpartum hemorrhage;

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.

Interventions

None listed

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Total perioperative blood lossMeasured 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 SpHbSpHb 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 measurementsMaternal 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026