A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

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.

• Estimated blood loss <1000 mL [Срок оценки: Date of randomization up to 30 days postpartum]
• Estimated blood loss >=1000 mL [Срок оценки: Date of randomization up to 30 days postpartum]
• Mechanical treatment of hemorrhage [Срок оценки: Date of randomization up to 30 days postpartum]
• Post-delivery packed red blood cell transfusion [Срок оценки: Date of randomization up to 30 days postpartum]
• Uterine artery embolization [Срок оценки: Date of randomization up to 30 days postpartum]
• Hysterectomy due to bleeding [Срок оценки: Date of randomization up to 30 days postpartum]
• Death [Срок оценки: Date of randomization up to 30 days postpartum]
• Medication to prevent bleeding [Срок оценки: Date of randomization to Postpartum hospital discharge (usually 2-4 days)]
• Estimated blood loss (mL) [Срок оценки: Date of randomization to Postpartum hospital discharge (usually 2-4 days)]
• Total packed red blood cells (units) [Срок оценки: Date of randomization to Postpartum hospital discharge (usually 2-4 days)]
• Postpartum hospital length of stay (hours) [Срок оценки: Date of randomization to Postpartum hospital discharge (usually 2-4 days)]
• Acute myocardial infarction [Срок оценки: Date of randomization up to 30 days postpartum]