Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513351
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Logistic Regression Prediction Model vs Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None