Clinical trial NCT01108471: Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) in Patients Undergoing Elective Cesarean Delivery
Official title: Study Comparing Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) With Laboratory Measurement in Patients Undergoing Elective Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: cesarean section; hemoglobin; postpartum hemorrhage;
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy pregnant patients undergoing elective cesarean delivery under neuraxial anesthesia

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total perioperative blood loss
timeFrame: Measured at the end of surgery (time frame cannto be specificied prior to study but estimated to be 60-90 mins)
measure: maternal SpHb
timeFrame: 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
measure: maternal venous hemoglobin measurements
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alex James Butwick
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.