Patients presenting for elective cesarean section will be screened for pre-procedural anemia. If the potential subject meets the selection criteria they will be presented with the option of participating in the study. Once consented the participant is randomized by envelope. The two groups studied are: standard of care with intraoperative cell salvage and standard of care without cell salvage. If the participant is randomized to the cell salvage group, the study team will notify the anesthesia and obstetrics (OB) team and will set up the cell salvage system per protocol. The primary end point is to determine the difference in postoperative hemoglobin at 48hrs, need and quantity of allogeneic blood product transfusion, length of hospital stay between the two groups studied. The secondary endpoints Investigate the impact of using IOCS on clinical parameters associated with maternal postpartum stability and well being and include estimation of blood loss, need for pressors, uterotonics, return to the operating room, uterine compression devices, ICU admission, postoperative blood product transfusion, IV iron supplementation, blood chemistry, coagulation parameters, oliguria, diagnosis of acute kidney injury, postoperative dialysis, acute respiratory distress syndrome, pulmonary edema, pneumonia, deep vein thrombosis, pulmonary embolism, oxygen requirement, new arrythmias APGAR scores, anemia fatigue scale at 24hr and 48 hrs, OBSQOR10 score 24 hours and 48 hours postpartum and 6 week postpartum EPDS score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
When the patient is randomized to this intervention the cell salvage machine will be set up for intraoperative use. The surgical team will collect blood from the surgical field into the cell salvage machine, which will process the blood for reinfusion. The volume of blood available for reinfusion is determined by the amount of blood lost which can be collected into the cell salvage system. The blood collected into the salvage system will be collected and processed per standard operating room procedure. At least 100mL of blood collected in the system are necessary for processing. If \>100mLs are collected, they will be processed and reinfused. The need for additional blood products and medications will be determined by the anesthesiology team based on the patient's hemodynamic status and will proceed per standard of care.
The Mount Sinai Hospital
New York, New York, United States
The difference in postoperative hemoglobin at 48hrs compared to preoperative baseline
The difference in postoperative hemoglobin at 48hrs
Time frame: Baseline and 48 hours postoperatively
Number of participants requiring allogeneic blood product transfusions
Need of allogeneic blood product transfusions
Time frame: at hospital discharge, likely within 120 hours from admission
Quantity of allogeneic blood product transfusion in number of packed red blood cells transfused
Quantity of allogeneic blood product transfusion
Time frame: at hospital discharge, likely within 120 hours from admission
Total blood volume transfused
Total blood volume transfused
Time frame: at hospital discharge, likely within 120 hours from admission
Length of hospital stay
Length of hospital stay
Time frame: at hospital discharge, likely within 120 hours from admission
Quantitative blood loss
The quantitative blood loss is obtained from the measured blood lost and accumulated into the measuring devices such as suction canisters and cell saver machine available in the operating room.
Time frame: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Number of participants being administered uterotonics
Uterotonic use is documented by the anesthesiologist when given intraoperatively. They include oxytocin, misoprostol, methylergonovine and carboprost.
Time frame: within 30 minutes of the end of the surgical procedure (approximately 2 hours)
Time to first dosage of pressors
When low blood pressure is measured postoperatively, pressors may be needed for hemodynamic stability. Possible blood pressors used postoperatively include phenylephrine, ephedrine, norepinephrine and epinephrine. The timing will be recorded.
Time frame: Until hospital discharge, likely within 120 hours from admission
APGAR Scores
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR scores will be obtained at 1 minute post-delivery.
Time frame: at 1 minute post-delivery
APGAR Scores
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR scores will be obtained at 5 minutes post-delivery.
Time frame: at 5 minutes post-delivery
Anemia-Fatigue Scale (FACIT-F) Score
The anemia-fatigue scale (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Each item is measured on a Likert scale which ranges from 1-5. The overall score ranges from 0-160, a higher score indicates greater quality of life.
Time frame: at 24 hours postpartum
Anemia-Fatigue Scale (FACIT-F) Score
The anemia-fatigue scale (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Each item is measured on a Likert scale which ranges from 1-5. The overall score ranges from 0-160, a higher score indicates greater quality of life.
Time frame: at 48 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
The Obstetric Quality of Recovery-10 patient-reported outcome measure (OBSQOR-10) at 24 hours postpartum is a validated tool for assessing the quality of postpartum recovery. Consists of 10 questions with a scale that ranges from 1-10.
Time frame: at 24 hours postpartum
The Obstetric Quality of Recovery-10 (OBSQOR-10) Score
The Obstetric Quality of Recovery-10 patient-reported outcome measure (OBSQOR-10) at 48 hours postpartum is a validated tool for assessing the quality of postpartum recovery. Consists of 10 questions with a scale that ranges from 1-10.
Time frame: at 48 hours postpartum
The Edinburgh Postnatal Depression Scale (EPDS) Score
The Edinburgh Postnatal Depression Scale (EPDS) is a short 10-item self-report questionnaire designed to identify mothers at risk for prenatal and postnatal depression will be performed at 6 weeks postpartum. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder.
Time frame: Up to 6 weeks postpartum
Use of postoperative uterine compression devices
In cases of postoperative bleeding, uterine compression devices may be needed. The use will be recorded.
Time frame: Until hospital discharge, likely within 120 hours from admission
Timing of postoperative uterine compression devices
In cases of postoperative bleeding, uterine compression devices may be needed. The timing will be recorded.
Time frame: Until hospital discharge, likely within 120 hours from admission
Use of postoperative blood product transfusion
Blood products may be needed postoperatively depending on patient symptoms and laboratory values. The timing of postoperative blood product transfusion will be recorded in relation to the end of procedure time. Possible blood products include packed red blood cells, platelets, fresh frozen plasma and cryoprecipitate.
Time frame: Until hospital discharge, likely within 120 hours from admission
Amount of postoperative blood product transfusion
Blood products may be needed postoperatively depending on patient symptoms and laboratory values. The amount of postoperative blood product transfusion will be recorded. Possible blood products include packed red blood cells, platelets, fresh frozen plasma and cryoprecipitate. Will be reported as number of units.
Time frame: Until hospital discharge, likely within 120 hours from admission
Number of participants receiving postoperative intravenous iron
Intravenous iron is used in some cases of postoperative anemia. The number of participants receiving postoperative intravenous iron will be recorded.
Time frame: Until hospital discharge, likely within 120 hours from admission
Number of participants admitted to intensive care unit (ICU)
When a higher level of care is needed that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The number of participants requiring ICU admission will be recorded.
Time frame: Until hospital discharge, likely within 120 hours from admission
The timing for intensive care unit (ICU)
When a higher level of care is needed that that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The timing for ICU admission will be recorded.
Time frame: Until hospital discharge, likely within 120 hours from admission
Reason for intensive care unit (ICU)
When a higher level of care is needed that that which can be provided on the post-operative labor and delivery floor, intensive care unit (ICU) admission may be required. The reason for ICU admission will be recorded.
Time frame: Until hospital discharge, likely within 120 hours from admission
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