Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Condition: Hemorrhage; Cesarean Section
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      A non-invasive hemoglobin monitor will be used during cesarean delivery and the values
      obtained will be compared to values obtained from traditional blood draw.
    

Detailed description: 
      Obstetric hemorrhage remains the leading cause of maternal death worldwide (2). The most
      common culprits are uterine atony, placental disorders, and delivery trauma. Current
      detection and management of hemorrhage is heavily based on clinical judgment and laboratory
      results. Interventions such as fluid resuscitation and blood transfusion are often initiated
      after a significant hemorrhage has already taken place. Early detection and treatment of this
      potentially life threatening obstetric complication is of upmost importance in the field of
      obstetrics. Traditional methods for assessing hemoglobin levels involve collecting the
      patient's blood and sending it to the laboratory for analysis via complete blood count (CBC).
      This involves a delay and often patients are continuing to hemorrhage while the CBC is being
      processed. Novel technology has recently been approved by the FDA, which can continuously
      assess hemoglobin levels via a non-invasive monitor. This device works as a pulse oximeter,
      which is placed on the index finger and uses infrared technology to estimate hemoglobin
      levels (1). Despite its validation and use in many patient populations such as trauma,
      neurosurgery and orthopedic surgery, data is lacking in an obstetric population. The
      investigator's hypothesis is that this device will enable clinicians detect hemorrhage early
      and initiate resuscitation such as fluid and/or blood transfusion before significant
      hemorrhage has taken place. This study will be a proof of concept prospective cohort study,
      in which the investigators will attempt to detect the association between intra-operative and
      postoperative continuous non-invasive hemoglobin monitoring and postpartum decrease in
      hemoglobin.

      Women undergoing primary cesarean delivery after failed induction of labor or repeat cesarean
      delivery after failed TOLAC (trial of labor after cesarean delivery), will be eligible for
      participation in this study. Prior to cesarean, all patients will have a CBC drawn. Masimo
      non-invasive hemoglobin monitor will be placed on their finger during delivery and remain in
      place until discharge from the recovery room. All patients will have CBC drawn on post
      operative day 1, as is the standard of care at our institution. Based on the drop in
      hemoglobin from pre-op to post-op day 1, patients will be separated into quartiles. The
      quartile with the highest drop in hemoglobin will be the "cases" and compared to the
      remainder of the quartiles or "controls." In addition, values obtained from the non-invasive
      monitor will be compared to those obtained from CBC.
    

Intervention name(s): Masimo Rainbow Pulse CO-oximeter
Intervention type(s): Device
Intervention description(s): Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery
Intervention model: Single Group Assignment
Intervention model description: All patients who agree to participate in the study will have the non-invasive hemoglobin monitor placed on their finger during delivery. The values obtained from the non invasive monitor will be masked to the clinicians during delivery. No medical decision making will be based on values obtained from the non-invasive monitor. After the patient leaves the recovery room, values obtained from the monitor will be compared to those obtained via blood draw. Patients will be separated into quartiles based on drop in hemoglobin (between pre-op and post-op day 1) and hemoglobin values obtained from the monitor will be compared between the quartiles.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hemoglobin; Cesarean delivery