A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
ConditionPost Partum Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHolly Ende
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Novel PPH Risk Prediction Model - Comparator Arm B
BehavioralPatients in this group will receive the standard care risk assessment with the addition of a recently developed, novel PPH risk prediction model, which will automatically calculate a patient's numerical risk of hemorrhage based on 21 risk factors. Elevated risk of hemorrhage (\>=3% predicted risk), as predicted by the model, will be linked to clinical decision support, including a best practice advisory with recommendations presented to providers for consideration when they access the patient's electronic health record.
Treatment groups
12,500 Participants
are divided into 2 treatment groupsGroup A: Standard Care - Comparator Arm ANo intervention 0 interventions
Group B: Novel PPH Risk Prediction Model - Comparator Arm BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Date of randomization to Postpartum hospital discharge (usually 2-4 days)2
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.
Time frame
30 days postpartumSecondary outcomes
1
Estimated blood loss <1000 mL
Number of patients with estimated blood loss \<1000mL
Time frame
Date of randomization up to 30 days postpartum2
Estimated blood loss >=1000 mL
Number of patients with estimated blood loss \>=1000mL
Time frame
Date of randomization up to 30 days postpartum3
Mechanical treatment of hemorrhage
Number of patients who required mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture)
Time frame
Date of randomization up to 30 days postpartum4
Post-delivery packed red blood cell transfusion
Number of patients who required post-delivery packed red blood cell transfusion
Time frame
Date of randomization up to 30 days postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Holly Ende
Lead sponsor
Vanderbilt University Medical Center
Sponsor institution
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov