Clinical trial NCT06513351: A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
Official title: Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Hemorrhage
Keywords: Post Partum Hemorrhage
Cesarean Section
Vaginal Birth
Risk Prediction
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2024-07-22
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Center Pragmatic Randomized Controlled Clinical Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center

Exclusion Criteria:

* All patients will be randomized at the time of admission to the obstetric service. Patients who are discharged prior to delivery will be excluded from subsequent analysis. Any patients with a pre-delivery planned hysterectomy (for placenta increta or percreta) will be excluded from the treatment algorithm and primary analysis.

Primary outcomes:
measure: Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge
timeFrame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
measure: Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum
timeFrame: 30 days postpartum
Secondary outcomes:
measure: Estimated blood loss <1000 mL
timeFrame: Date of randomization up to 30 days postpartum
measure: Estimated blood loss >=1000 mL
timeFrame: Date of randomization up to 30 days postpartum
measure: Mechanical treatment of hemorrhage
timeFrame: Date of randomization up to 30 days postpartum
measure: Post-delivery packed red blood cell transfusion
timeFrame: Date of randomization up to 30 days postpartum
measure: Uterine artery embolization
timeFrame: Date of randomization up to 30 days postpartum
measure: Hysterectomy due to bleeding
timeFrame: Date of randomization up to 30 days postpartum
measure: Death
timeFrame: Date of randomization up to 30 days postpartum
measure: Medication to prevent bleeding
timeFrame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
measure: Estimated blood loss (mL)
timeFrame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
measure: Total packed red blood cells (units)
timeFrame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
measure: Postpartum hospital length of stay (hours)
timeFrame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
measure: Acute myocardial infarction
timeFrame: Date of randomization up to 30 days postpartum
measure: Aneurysm
timeFrame: Date of randomization up to 30 days postpartum
measure: Acute renal failure
timeFrame: Date of randomization up to 30 days postpartum
measure: Acute respiratory distress syndrome
timeFrame: Date of randomization up to 30 days postpartum
measure: Amniotic fluid embolism
timeFrame: Date of randomization up to 30 days postpartum
measure: Cardiac arrest/ventricular fibrillation
timeFrame: Date of randomization up to 30 days postpartum
measure: Conversion of cardiac rhythm
timeFrame: Date of randomization up to 30 days postpartum
measure: Disseminated intravascular coagulation
timeFrame: Date of randomization up to 30 days postpartum
measure: Blood transfusion
timeFrame: Date of randomization up to 30 days postpartum
measure: Eclampsia
timeFrame: Date of randomization up to 30 days postpartum
measure: Heart failure/arrest during surgery or procedure
timeFrame: Date of randomization up to 30 days postpartum
measure: Puerperal cerebrovascular disorders
timeFrame: Date of randomization up to 30 days postpartum
measure: Pulmonary edema/acute heart failure
timeFrame: Date of randomization up to 30 days postpartum
measure: Severe anesthesia complications
timeFrame: Date of randomization up to 30 days postpartum
measure: Sepsis
timeFrame: Date of randomization up to 30 days postpartum
measure: Shock
timeFrame: Date of randomization up to 30 days postpartum
measure: Sickle cell disease with crisis
timeFrame: Date of randomization up to 30 days postpartum
measure: Air and thrombotic embolism
timeFrame: Date of randomization up to 30 days postpartum
measure: Hysterectomy
timeFrame: Date of randomization up to 30 days postpartum
measure: Temporary tracheostomy
timeFrame: Date of randomization up to 30 days postpartum
measure: Ventilation
timeFrame: Date of randomization up to 30 days postpartum
measure: Post-delivery ICU admission
timeFrame: Date of randomization up to 30 days postpartum
measure: Time from delivery to OR for patients requiring operative repair
timeFrame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
measure: Fetal APGAR score at 1 minute
timeFrame: 1 minute post-delivery
measure: Fetal APGAR score at 5 minutes
timeFrame: 5 minutes post-delivery
measure: Fetal APGAR score at 10 minutes
timeFrame: 10 minutes post-delivery
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Holly Ende, MD
role: PRINCIPAL_INVESTIGATOR
References: