Post Partum HemorrhageNCT06513351
A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
A study testing Novel PPH Risk Prediction Model - Comparator Arm B in people with Post Partum Hemorrhage, run by Holly Ende at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Novel PPH Risk Prediction Model - Comparator Arm B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Holly Ende, MD, 615-322-8476, holly.ende@vumc.org
Holly Ende, MD
About this study
Official title: Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled 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.
Read more
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.
Read the 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.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Novel PPH Risk Prediction Model - Comparator Arm B
- Keywords
- Post Partum Hemorrhage, Cesarean Section, Vaginal Birth, Risk Prediction
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel PPH Risk Prediction Model - Comparator Arm BBehavioural
Patients 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care - Comparator Arm A | No intervention | 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 | Active comparator | Standard Care with addition of a recently developed, novel PPH risk prediction model. Receives: Behavioral: Novel PPH Risk Prediction Model - Comparator Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days postpartum
Secondary outcomes (37)
Estimated blood loss <1000 mL
Number of patients with estimated blood loss <1000mL
Measured: Date of randomization up to 30 days postpartum
Estimated blood loss >=1000 mL
Number of patients with estimated blood loss >=1000mL
Measured: 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)
Measured: 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
Measured: Date of randomization up to 30 days postpartum
Uterine artery embolization
Number of patients who required uterine artery embolization
Measured: Date of randomization up to 30 days postpartum
Hysterectomy due to bleeding
Number of patients requiring a hysterectomy due to bleeding
Measured: Date of randomization up to 30 days postpartum
Death
Number of patients who died within 30 days postpartum
Measured: Date of randomization up to 30 days postpartum
Medication to prevent bleeding
Number of patients who received medication to prevent bleeding
Measured: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Estimated blood loss (mL)
median and interquartile range for all patients
Measured: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Total packed red blood cells (units)
median and interquartile range for all patients
Measured: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Postpartum hospital length of stay (hours)
median and interquartile range for all patients
Measured: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Acute myocardial infarction
Number of patients who experienced an acute myocardial infarction
Measured: Date of randomization up to 30 days postpartum
Aneurysm
Number of patients who experienced an aneurysm
Measured: Date of randomization up to 30 days postpartum
Acute renal failure
Number of patients who experienced acute renal failure
Measured: Date of randomization up to 30 days postpartum
Acute respiratory distress syndrome
Number of patients who experienced acute respiratory distress syndrome
Measured: Date of randomization up to 30 days postpartum
Amniotic fluid embolism
Number of patients who experienced amniotic fluid embolism
Measured: Date of randomization up to 30 days postpartum
Cardiac arrest/ventricular fibrillation
Number of patients who experienced cardiac arrest/ventricular fibrillation
Measured: Date of randomization up to 30 days postpartum
Conversion of cardiac rhythm
Number of patients who required conversion of cardiac rhythm
Measured: Date of randomization up to 30 days postpartum
Disseminated intravascular coagulation
Number of patients who experienced disseminated intravascular coagulation
Measured: Date of randomization up to 30 days postpartum
Blood transfusion
Number of patients who required a blood transfusion
Measured: Date of randomization up to 30 days postpartum
Eclampsia
Number of patients who experienced eclampsia
Measured: 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
Measured: Date of randomization up to 30 days postpartum
Puerperal cerebrovascular disorders
Number of patients who experienced puerperal cerebrovascular disorders
Measured: Date of randomization up to 30 days postpartum
Pulmonary edema/acute heart failure
Number of patients who experienced pulmonary edema/acute heart failure
Measured: Date of randomization up to 30 days postpartum
Severe anesthesia complications
Number of patients who experienced severe anesthesia complications
Measured: Date of randomization up to 30 days postpartum
Sepsis
Number of patients who experienced sepsis
Measured: Date of randomization up to 30 days postpartum
Shock
Number of patients who experienced shock
Measured: Date of randomization up to 30 days postpartum
Sickle cell disease with crisis
Number of patients who experienced sickle cell disease with crisis
Measured: Date of randomization up to 30 days postpartum
Air and thrombotic embolism
Number of patients who experienced air and thrombotic embolism
Measured: Date of randomization up to 30 days postpartum
Hysterectomy
Number of patients who required a hysterectomy
Measured: Date of randomization up to 30 days postpartum
Temporary tracheostomy
Number of patients who required a temporary tracheostomy
Measured: Date of randomization up to 30 days postpartum
Ventilation
Number of patients who required ventilation
Measured: Date of randomization up to 30 days postpartum
Post-delivery ICU admission
Number of patients who required ICU admission following delivery
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jan 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Center Pragmatic Randomized Controlled Clinical Trial
- Masking
- None (open label)
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holly Ende
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor-investigator, Holly Ende, Vanderbilt University Medical Center
- Investigators
- Holly Ende, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513351
- Sponsor's protocol ID
- 240187
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06513351
- Acronym / sponsor ID
- 240187
- Conditions
- Post Partum Hemorrhage
- Keywords
- Post Partum Hemorrhage, Cesarean Section, Vaginal Birth, Risk Prediction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- Holly EndeUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Center Pragmatic Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care - Comparator Arm A | No intervention | –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 | Active comparator | Behavioral: Novel PPH Risk Prediction Model - Comparator Arm BStandard Care with addition of a recently developed, novel PPH risk prediction model. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel PPH Risk Prediction Model - Comparator Arm BPatients 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. | Behavioural | Novel PPH Risk Prediction Model - Comparator Arm B |
Primary outcome
Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge
Time frame: 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.
Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum
Time frame: 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.
37 secondary outcomes
Estimated blood loss <1000 mL
Time frame: Date of randomization up to 30 days postpartum
Estimated blood loss >=1000 mL
Time frame: Date of randomization up to 30 days postpartum
Mechanical treatment of hemorrhage
Time frame: Date of randomization up to 30 days postpartum
Post-delivery packed red blood cell transfusion
Time frame: Date of randomization up to 30 days postpartum
Uterine artery embolization
Time frame: Date of randomization up to 30 days postpartum
Hysterectomy due to bleeding
Time frame: Date of randomization up to 30 days postpartum
Death
Time frame: Date of randomization up to 30 days postpartum
Medication to prevent bleeding
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Estimated blood loss (mL)
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Total packed red blood cells (units)
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Postpartum hospital length of stay (hours)
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Acute myocardial infarction
Time frame: Date of randomization up to 30 days postpartum
Aneurysm
Time frame: Date of randomization up to 30 days postpartum
Acute renal failure
Time frame: Date of randomization up to 30 days postpartum
Acute respiratory distress syndrome
Time frame: Date of randomization up to 30 days postpartum
Amniotic fluid embolism
Time frame: Date of randomization up to 30 days postpartum
Cardiac arrest/ventricular fibrillation
Time frame: Date of randomization up to 30 days postpartum
Conversion of cardiac rhythm
Time frame: Date of randomization up to 30 days postpartum
Disseminated intravascular coagulation
Time frame: Date of randomization up to 30 days postpartum
Blood transfusion
Time frame: Date of randomization up to 30 days postpartum
Eclampsia
Time frame: Date of randomization up to 30 days postpartum
Heart failure/arrest during surgery or procedure
Time frame: Date of randomization up to 30 days postpartum
Puerperal cerebrovascular disorders
Time frame: Date of randomization up to 30 days postpartum
Pulmonary edema/acute heart failure
Time frame: Date of randomization up to 30 days postpartum
Severe anesthesia complications
Time frame: Date of randomization up to 30 days postpartum
Sepsis
Time frame: Date of randomization up to 30 days postpartum
Shock
Time frame: Date of randomization up to 30 days postpartum
Sickle cell disease with crisis
Time frame: Date of randomization up to 30 days postpartum
Air and thrombotic embolism
Time frame: Date of randomization up to 30 days postpartum
Hysterectomy
Time frame: Date of randomization up to 30 days postpartum
Temporary tracheostomy
Time frame: Date of randomization up to 30 days postpartum
Ventilation
Time frame: Date of randomization up to 30 days postpartum
Post-delivery ICU admission
Time frame: Date of randomization up to 30 days postpartum
Time from delivery to OR for patients requiring operative repair
Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Fetal APGAR score at 1 minute
Time frame: 1 minute post-delivery
Fetal APGAR score at 5 minutes
Time frame: 5 minutes post-delivery
Fetal APGAR score at 10 minutes
Time frame: 10 minutes post-delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Post Partum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
RecruitingObservational study
Hemoglobin Testing in Pregnant Patients
Post Partum Hemorrhage, Anemia of Pregnancy
Recruiting
Effect of Simulation-Based Postpartum Hemorrhage Training on Team Performance in Senior Anesthesiology Teams
Postpartum Hemorrhage, Simulation Based Medical Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holly Ende, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel PPH Risk Prediction Model - Comparator Arm B in people with Post Partum Hemorrhage, run by Holly Ende at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Ende, MD (615-322-8476, holly.ende@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge (time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.