Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12,500
- 试验地点
- 2
- 主要终点
- Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center
排除标准
- •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.
研究组 & 干预措施
Standard Care - Comparator Arm A
Standard Care, which includes a category-based risk assessment tool as part of nursing admission workflow. The prophylactic interventions in the intervention are recommended by the tool but not specifically tied to provider-facing clinical decision support.
Novel PPH Risk Prediction Model - Comparator Arm B
Standard Care with addition of a recently developed, novel PPH risk prediction model.
干预措施: Novel PPH Risk Prediction Model - Comparator Arm B (Behavioral)
结局指标
主要结局
Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum
时间窗: 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.
Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge
时间窗: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
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.
次要结局
- Air and thrombotic embolism(Date of randomization up to 30 days postpartum)
- Medication to prevent bleeding(Date of randomization to Postpartum hospital discharge (usually 2-4 days))
- Total packed red blood cells (units)(Date of randomization to Postpartum hospital discharge (usually 2-4 days))
- Estimated blood loss (mL)(Date of randomization to Postpartum hospital discharge (usually 2-4 days))
- Postpartum hospital length of stay (hours)(Date of randomization to Postpartum hospital discharge (usually 2-4 days))
- Estimated blood loss <1000 mL(Date of randomization up to 30 days postpartum)
- Estimated blood loss >=1000 mL(Date of randomization up to 30 days postpartum)
- Post-delivery packed red blood cell transfusion(Date of randomization up to 30 days postpartum)
- Uterine artery embolization(Date of randomization up to 30 days postpartum)
- Hysterectomy due to bleeding(Date of randomization up to 30 days postpartum)
- Acute renal failure(Date of randomization up to 30 days postpartum)
- Mechanical treatment of hemorrhage(Date of randomization up to 30 days postpartum)
- Death(Date of randomization up to 30 days postpartum)
- Puerperal cerebrovascular disorders(Date of randomization up to 30 days postpartum)
- Sepsis(Date of randomization up to 30 days postpartum)
- Acute myocardial infarction(Date of randomization up to 30 days postpartum)
- Amniotic fluid embolism(Date of randomization up to 30 days postpartum)
- Shock(Date of randomization up to 30 days postpartum)
- Aneurysm(Date of randomization up to 30 days postpartum)
- Conversion of cardiac rhythm(Date of randomization up to 30 days postpartum)
- Disseminated intravascular coagulation(Date of randomization up to 30 days postpartum)
- Blood transfusion(Date of randomization up to 30 days postpartum)
- Pulmonary edema/acute heart failure(Date of randomization up to 30 days postpartum)
- Hysterectomy(Date of randomization up to 30 days postpartum)
- Time from delivery to OR for patients requiring operative repair(Date of randomization to Postpartum hospital discharge (usually 2-4 days))
- Fetal APGAR score at 10 minutes(10 minutes post-delivery)
- Acute respiratory distress syndrome(Date of randomization up to 30 days postpartum)
- Severe anesthesia complications(Date of randomization up to 30 days postpartum)
- Post-delivery ICU admission(Date of randomization up to 30 days postpartum)
- Cardiac arrest/ventricular fibrillation(Date of randomization up to 30 days postpartum)
- Eclampsia(Date of randomization up to 30 days postpartum)
- Heart failure/arrest during surgery or procedure(Date of randomization up to 30 days postpartum)
- Sickle cell disease with crisis(Date of randomization up to 30 days postpartum)
- Temporary tracheostomy(Date of randomization up to 30 days postpartum)
- Ventilation(Date of randomization up to 30 days postpartum)
- Fetal APGAR score at 1 minute(1 minute post-delivery)
- Fetal APGAR score at 5 minutes(5 minutes post-delivery)
研究者
Holly Ende
Associate Professor of Anesthesiology
Vanderbilt University Medical Center