This research project aims to enhance the safety of childbirth by using advanced computer models to predict the risk of postpartum hemorrhage (PPH). PPH is a significant concern for mothers during and after delivery. Current risk assessment tools are basic and do not adapt to changing conditions. This study will investigate whether a new and recently validated model for predicting PPH, combined with a provider-facing Best Practice Advisory (BPA) regarding currently recommended strategies triggered by an increased predicted risk, can improve perinatal outcomes. This study will compare the current category based risk assessment tool with a new, enhanced prediction model which calculates risk based on 21 factors, automatically updates as new information becomes available during labor and, if elevated, provides a provider-facing Best Practice Advisory (BPA) recommending consideration of strategies that are institutionally agreed to represent high-quality practice. Investigators hypothesize that the enhanced care approach will result in improved perinatal outcomes. The goal of the study is to improve the wellbeing of mothers during childbirth by harnessing the power of modern technology and data analysis.
Postpartum hemorrhage (PPH) is a common complication following vaginal or cesarean delivery and contributes significantly to maternal morbidity and mortality in the United States. There are numerous clinical factors which contribute to a patient's risk of developing PPH. Utilization of an evidence-based tool for PPH risk prediction is recommended by national societies and required by the Joint Commission. Most currently used tools are category based and assign a low, medium, or high risk of hemorrhage. These tools fail to take advantage of the vast amounts of data and computing power available via modern electronic medical records. Predictive modeling and informatics-based solutions could help to modernize PPH risk prediction and improve patient outcomes. This study proposes to continue standard of care risk assessment for all patients, including those randomized to the intervention arm (ARM B). Those patients in the intervention arm (ARM B) will have an additional risk prediction displayed, which will show the quantitative output from the logistic regression PPH risk prediction model, (validated in a previous study). In addition to this display, patients above a preset threshold of 3% risk will have a Best Practice Advisory (BPA) deployed to clinicians with recommended actions. These recommended actions, including the prophylactic use of tranexamic acid and second-line uterotonics, are supported by best evidence in those patients deemed to be at elevated a priori risk of PPH. These prophylactic treatments are accepted standard of care for those patients deemed high risk, and may be administered, at the discretion of the covering clinician, to patients rated high risk by the current risk assessment tool in the comparator arm (Arm A) of the study. The recommendations within the best practice advisory serve as a reminder of best practices as defined by the department and providers are not forced to follow the recommendations of the best practice advisory.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
10,000
Patients in this group will receive the standard care risk assessment with the addition of a recently developed, novel PPH risk prediction model, which will automatically calculate a patient's numerical risk of hemorrhage based on 21 risk factors. Elevated risk of hemorrhage (\>=3% predicted risk), as predicted by the model, will be linked to clinical decision support, including a best practice advisory with recommendations presented to providers for consideration when they access the patient's electronic health record.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGNumerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge
Patients will be assigned the most severe morbidity and mortality outcome score based on a range of criteria from 1 to 7 with 1 being the least severe and 7 being the most severe outcome. 1 is Estimated blood loss \<1000 mL, 2 is Estimated blood loss \>=1000 mL, 3 is Mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture), 4 is Post-delivery red blood cell transfusion, 5 is Uterine artery embolization, 6 is Hysterectomy due to bleeding, and 7 is Death. For example, a patient who experiences an estimated blood loss \>=1000mL and does not experience another more serious outcome would receive a score of 2, whereas a patient who requires a hysterectomy due to bleeding might meet several of the criteria, but would receive a score of 6, as this is the most severe criteria they experience.
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum
Patients will be assigned the most severe morbidity and mortality outcome score based on a range of criteria from 1 to 7 with 1 being the least severe and 7 being the most severe outcome. 1 is Estimated blood loss \<1000 mL, 2 is Estimated blood loss \>=1000 mL, 3 is Mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture), 4 is Post-delivery red blood cell transfusion, 5 is Uterine artery embolization, 6 is Hysterectomy due to bleeding, and 7 is Death. For example, a patient who experiences an estimated blood loss \>=1000mL and does not experience another more serious outcome would receive a score of 2, whereas a patient who requires a hysterectomy due to bleeding might meet several of the criteria, but would receive a score of 6, as this is the most severe criteria they experience.
Time frame: 30 days postpartum
Estimated blood loss <1000 mL
Number of patients with estimated blood loss \<1000mL
Time frame: Date of randomization up to 30 days postpartum
Estimated blood loss >=1000 mL
Number of patients with estimated blood loss \>=1000mL
Time frame: Date of randomization up to 30 days postpartum
Mechanical treatment of hemorrhage
Number of patients who required mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture)
Time frame: Date of randomization up to 30 days postpartum
Post-delivery packed red blood cell transfusion
Number of patients who required post-delivery packed red blood cell transfusion
Time frame: Date of randomization up to 30 days postpartum
Uterine artery embolization
Number of patients who required uterine artery embolization
Time frame: Date of randomization up to 30 days postpartum
Hysterectomy due to bleeding
Number of patients requiring a hysterectomy due to bleeding
Time frame: Date of randomization up to 30 days postpartum
Death
Number of patients who died within 30 days postpartum
Time frame: Date of randomization up to 30 days postpartum
Medication to prevent bleeding
Number of patients who received medication to prevent bleeding
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Estimated blood loss (mL)
median and interquartile range for all patients
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Total packed red blood cells (units)
median and interquartile range for all patients
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Postpartum hospital length of stay (hours)
median and interquartile range for all patients
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Acute myocardial infarction
Number of patients who experienced an acute myocardial infarction
Time frame: Date of randomization up to 30 days postpartum
Aneurysm
Number of patients who experienced an aneurysm
Time frame: Date of randomization up to 30 days postpartum
Acute renal failure
Number of patients who experienced acute renal failure
Time frame: Date of randomization up to 30 days postpartum
Acute respiratory distress syndrome
Number of patients who experienced acute respiratory distress syndrome
Time frame: Date of randomization up to 30 days postpartum
Amniotic fluid embolism
Number of patients who experienced amniotic fluid embolism
Time frame: Date of randomization up to 30 days postpartum
Cardiac arrest/ventricular fibrillation
Number of patients who experienced cardiac arrest/ventricular fibrillation
Time frame: Date of randomization up to 30 days postpartum
Conversion of cardiac rhythm
Number of patients who required conversion of cardiac rhythm
Time frame: Date of randomization up to 30 days postpartum
Disseminated intravascular coagulation
Number of patients who experienced disseminated intravascular coagulation
Time frame: Date of randomization up to 30 days postpartum
Blood transfusion
Number of patients who required a blood transfusion
Time frame: Date of randomization up to 30 days postpartum
Eclampsia
Number of patients who experienced eclampsia
Time frame: Date of randomization up to 30 days postpartum
Heart failure/arrest during surgery or procedure
Number of patients who experienced heart failure/arrest during surgery or procedure
Time frame: Date of randomization up to 30 days postpartum
Puerperal cerebrovascular disorders
Number of patients who experienced puerperal cerebrovascular disorders
Time frame: Date of randomization up to 30 days postpartum
Pulmonary edema/acute heart failure
Number of patients who experienced pulmonary edema/acute heart failure
Time frame: Date of randomization up to 30 days postpartum
Severe anesthesia complications
Number of patients who experienced severe anesthesia complications
Time frame: Date of randomization up to 30 days postpartum
Sepsis
Number of patients who experienced sepsis
Time frame: Date of randomization up to 30 days postpartum
Shock
Number of patients who experienced shock
Time frame: Date of randomization up to 30 days postpartum
Sickle cell disease with crisis
Number of patients who experienced sickle cell disease with crisis
Time frame: Date of randomization up to 30 days postpartum
Air and thrombotic embolism
Number of patients who experienced air and thrombotic embolism
Time frame: Date of randomization up to 30 days postpartum
Hysterectomy
Number of patients who required a hysterectomy
Time frame: Date of randomization up to 30 days postpartum
Temporary tracheostomy
Number of patients who required a temporary tracheostomy
Time frame: Date of randomization up to 30 days postpartum
Ventilation
Number of patients who required ventilation
Time frame: Date of randomization up to 30 days postpartum
Post-delivery ICU admission
Number of patients who required ICU admission following delivery
Time frame: Date of randomization up to 30 days postpartum
Time from delivery to OR for patients requiring operative repair
Time from delivery to entry into the operating room for dilation and curettage, or operative repair of vaginal/cervical laceration
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Fetal APGAR score at 1 minute
The median and interquartile range of the APGAR score will be reported for all patients. The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria: appearance (skin color), pulse (heart rate), grimace (reflex irritability), activity (muscle tone) and respiration on a scale from 0 to 2. Apgar total score (obtained by summing up values from all five items) ranges from 0 to 10 with a score of 0 expressing the worst neonatal status and a score of 10 the best status.
Time frame: 1 minute post-delivery
Fetal APGAR score at 5 minutes
The median and interquartile range of the APGAR score will be reported for all patients. The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria: appearance (skin color), pulse (heart rate), grimace (reflex irritability), activity (muscle tone) and respiration on a scale from 0 to 2. Apgar total score (obtained by summing up values from all five items) ranges from 0 to 10 with a score of 0 expressing the worst neonatal status and a score of 10 the best status.
Time frame: 5 minutes post-delivery
Fetal APGAR score at 10 minutes
The median and interquartile range of the APGAR score will be reported for all patients. The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria: appearance (skin color), pulse (heart rate), grimace (reflex irritability), activity (muscle tone) and respiration on a scale from 0 to 2. Apgar total score (obtained by summing up values from all five items) ranges from 0 to 10 with a score of 0 expressing the worst neonatal status and a score of 10 the best status.
Time frame: 10 minutes post-delivery
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