A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
NCT Number: NCT06513351
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Partum Hemorrhage
Interventions: BEHAVIORAL: Novel PPH Risk Prediction Model - Comparator Arm B
Sponsor: Holly Ende
Collaborators: Vanderbilt University Medical Center
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10
Completion Date: 2027-07
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37212, United States

Summary:
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.

Primary Outcome Measures: Numerical 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., 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., 30 days postpartum
Secondary Outcome Measures: Estimated blood loss <1000 mL, Number of patients with estimated blood loss \<1000mL, Date of randomization up to 30 days postpartum|Estimated blood loss >=1000 mL, Number of patients with estimated blood loss \>=1000mL, 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), 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, Date of randomization up to 30 days postpartum|Uterine artery embolization, Number of patients who required uterine artery embolization, Date of randomization up to 30 days postpartum|Hysterectomy due to bleeding, Number of patients requiring a hysterectomy due to bleeding, Date of randomization up to 30 days postpartum|Death, Number of patients who died within 30 days postpartum, Date of randomization up to 30 days postpartum|Medication to prevent bleeding, Number of patients who received medication to prevent bleeding, Date of randomization to Postpartum hospital discharge (usually 2-4 days)|Estimated blood loss (mL), median and interquartile range for all patients, Date of randomization to Postpartum hospital discharge (usually 2-4 days)|Total packed red blood cells (units), median and interquartile range for all patients, Date of randomization to Postpartum hospital discharge (usually 2-4 days)|Postpartum hospital length of stay (hours), median and interquartile range for all patients, Date of randomization to Postpartum hospital discharge (usually 2-4 days)|Acute myocardial infarction, Number of patients who experienced an acute myocardial infarction, Date of randomization up to 30 days postpartum|Aneurysm, Number of patients who experienced an aneurysm, Date of randomization up to 30 days postpartum|Acute renal failure, Number of patients who experienced acute renal failure, Date of randomization up to 30 days postpartum|Acute respiratory distress syndrome, Number of patients who experienced acute respiratory distress syndrome, Date of randomization up to 30 days postpartum|Amniotic fluid embolism, Number of patients who experienced amniotic fluid embolism, Date of randomization up to 30 days postpartum|Cardiac arrest/ventricular fibrillation, Number of patients who experienced cardiac arrest/ventricular fibrillation, Date of randomization up to 30 days postpartum|Conversion of cardiac rhythm, Number of patients who required conversion of cardiac rhythm, Date of randomization up to 30 days postpartum|Disseminated intravascular coagulation, Number of patients who experienced disseminated intravascular coagulation, Date of randomization up to 30 days postpartum|Blood transfusion, Number of patients who required a blood transfusion, Date of randomization up to 30 days postpartum|Eclampsia, Number of patients who experienced eclampsia, 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, Date of randomization up to 30 days postpartum|Puerperal cerebrovascular disorders, Number of patients who experienced puerperal cerebrovascular disorders, Date of randomization up to 30 days postpartum|Pulmonary edema/acute heart failure, Number of patients who experienced pulmonary edema/acute heart failure, Date of randomization up to 30 days postpartum|Severe anesthesia complications, Number of patients who experienced severe anesthesia complications, Date of randomization up to 30 days postpartum|Sepsis, Number of patients who experienced sepsis, Date of randomization up to 30 days postpartum|Shock, Number of patients who experienced shock, Date of randomization up to 30 days postpartum|Sickle cell disease with crisis, Number of patients who experienced sickle cell disease with crisis, Date of randomization up to 30 days postpartum|Air and thrombotic embolism, Number of patients who experienced air and thrombotic embolism, Date of randomization up to 30 days postpartum|Hysterectomy, Number of patients who required a hysterectomy, Date of randomization up to 30 days postpartum|Temporary tracheostomy, Number of patients who required a temporary tracheostomy, Date of randomization up to 30 days postpartum|Ventilation, Number of patients who required ventilation, Date of randomization up to 30 days postpartum|Post-delivery ICU admission, Number of patients who required ICU admission following delivery, 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, 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., 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., 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., 10 minutes post-delivery