Post Partum HemorrhageELUSIVENCT04277962
Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
A study testing Triton L and D system for estimation of blood loss at time of vaginal delivery in people with Post Partum Hemorrhage and Blood Loss, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Hemorrhage, Blood Loss, Vaginal Bleeding
- What is being tested?
- Triton L and D system for estimation of blood loss at time of vaginal delivery
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Criteria for inclusion of subjects:
Pregnant women between the ages of 18-50. Plan of care is vaginal delivery.
Criteria for exclusion of subjects:
Incarcerated patients. Patient unwilling or unable to provide consent. Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).
Placenta previa or other known placental anomalies. Any contraindications to vaginal delivery. Enrolled in another trial that may affect outcome.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. If patients agree to participate, a CBC (complete blood count) will be obtained via venous puncture routine in our facility as part of the admission labs which will be around 10 cc of blood. The device will be used during the delivery in laboring room. The device will be used to assess QBL (quantitative blood loss) by the research staff only and results/ QBL assessment will be masked to the clinical team. Unmasking will only occur following study completion with purpose to perform data analysis. Patient management will be according to the clinical team without the knowledge of the QBL. All patients undergo a CBC postpartum as part of post-partum evaluation, this will also be performed by venipuncture where 10 cc of blood will be collected. The drop in Hgb (hemoglobin) between the pre and post partum CBCs will be calculated for each patient. The post-partum CBC will be collected approximately 24-30 hours from delivery as standard in our unit. The blood will be collected from each patient by the nursing staff who are experienced in withdrawing blood. Patients will be divided into quartiles of Hgb. Cases will be those patients whose Hgb is in the upper quartile, while controls will be those patients whose Hgb is in the lower 3 quartiles. We will be comparing visual EBL (estimated blood loss) by standard clinical assessment versus the QBL result from the device between cases and controls.
The Triton L\&D (labor and delivery) system which comprises of the device, software analysis and staff training will be supplied by the manufacturer free of charge. Research staff will be trained by the manufacturer. We will be offering our skills, fellows, midwifes and residents, who will be collecting data and we will be performing the data analysis. Results will be available to the manufacturer after results are completed. The results of this study will be presented in conferences or published in a peer-review journal.
Demographic information will be obtained from the electronic medical record. The data will be kept on a password secured University of Texas Medical Branch (UTMB) computer. An encrypted USB flash drive will be used to transfer data. The data will be identified and linked to the patient using the medical record number. During data analysis, all patient identifiers will be deleted.
Read the detailed description
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally (1). An estimated blood loss (EBL) in excess of 500 mL following a vaginal birth has often been used for the definition of PPH, but the average volume of blood lost at delivery can approach these amounts when actually measured rather than estimated (2). More than half of all maternal deaths occur within 24 hours of delivery, most commonly from excessive bleeding (3). Worldwide, 140,000 women succumb to postpartum hemorrhage each year. The most common antecedents to postpartum hemorrhage are uterine atony, placental disorders, and trauma during delivery. Improving maternal health worldwide is one of the WHO's 8 Millennium Developmental Goals. The prevention and treatment of PPH is an essential step towards the achievement of that goal (4).
Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation (5). Traditionally, the clinicians performing the vaginal delivery would estimate the blood loss by visually assessing the blood collected in the delivery drape drain and counting the number of lap sponges used thru out the delivery. Current detection and management of hemorrhage is heavily based on clinical judgment, which often leads to delay in recognition and intervention. Often, interventions such as fluid resuscitation and blood transfusion are not initiated until significant hemorrhage has already taken place. The traditional method for estimating blood loss is based on the clinician and nursing staff's subjective assessment that is severely limited by human error and the presence of large volumes of amniotic fluid (6).
Early detection and treatment of this potentially life-threatening obstetric complication is of utmost importance in the field of obstetrics. Simulations and didactic training have been shown to improve visual estimations, but there are still poor associations between experience level and accuracy, and a significant decay in blood loss estimation skills over time (7).
The Triton L\&D system (Gauss Surgical, Inc., Menlo Park, CA) is an FDA-cleared mobile application on a tablet computer (iPad) that facilitates quantification of blood loss (QBL) by providing an easy to use process and user interface. Dry weights of all potential blood containing substrates are built-in to the device allowing batch weighing with automatic subtraction of dry weights. There is also a V-drape simulator accounting for collected fluids with automatic subtraction of a measured amount of amniotic fluid.
QBL is not regularly used at UTMB. Although widely recommended, little data is available to support its use in the obstetrical population. We believe that gathering further evidence regarding its value is appropriate.
Our hypothesis is that use of this device for QBL will enable clinicians to objectively measure blood loss in real-time.
This study will be a prospective cohort study, in which we will evaluate two methods of evaluating blood loss during vaginal delivery (usual visual EBL assessment versus Device QBL). Of note, the subjects consented will be used as self-controls.
- Conditions
- Post Partum Hemorrhage, Blood Loss, Vaginal Bleeding, Vaginal Delivery
- Being tested
- Triton L and D system for estimation of blood loss at time of vaginal delivery
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triton L and D system for estimation of blood loss at time of vaginal deliveryDevice
The Triton L\&D system (Gauss Surgical, Inc., Menlo Park, CA) is an FDA-cleared mobile application on a tablet computer (iPad) that facilitates quantification of blood loss (QBL) by providing an easy to use process and user interface. Dry weights of all potential blood containing substrates are built-in to the device allowing batch weighing with automatic subtraction of dry weights. There is also a V-drape simulator accounting for collected fluids with automatic subtraction of a measured amount of amniotic fluid.
| Study group | Role | What they receive |
|---|---|---|
| Patients having vaginal delivery | Experimental | EBL will be estimated visually vs quantitatively at time of vaginal delivery. Receives: Device: Triton L and D system for estimation of blood loss at time of vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Blood Loss Between Cases and Controls Using Clinical Estimate (Visual EBL) Versus Device Assessment (QBL).
Measured: At time of vaginal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 May 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Sponsor did not want to pursue and COVID 19 delays
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Saad, MD, Study director, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277962
- Sponsor's protocol ID
- 19-0147
- Acronym
- ELUSIVE
- Status last verified
- May 2023
- First submitted
- 18 Feb 2020
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
- ClinicalTrials.gov ID
- NCT04277962
- Acronym / sponsor ID
- ELUSIVE / 19-0147
- Conditions
- Post Partum Hemorrhage, Blood Loss, Vaginal Bleeding, Vaginal Delivery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor did not want to pursue and COVID 19 delays
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. If patients agree to participate, a CBC (complete blood count) will be obtained via venous puncture routine in our facility as part of the admission labs which will be around 10 cc of blood. The device will be used during the delivery in laboring room. The device will be used to assess QBL (quantitative blood loss) by the research staff only and results/ QBL assessment will be masked to the clinical team. Unmasking will only occur following study completion with purpose to perform data analysis. Patient management will be according to the clinical team without the knowledge of the QBL. All patients undergo a CBC postpartum as part of post-partum evaluation, this will also be performed by venipuncture where 10 cc of blood will be collected. The drop in Hgb (hemoglobin) between the pre and post partum CBCs will be calculated for each patient. The post-partum CBC will be collected approximately 24-30 hours from delivery as standard in our unit. The blood will be collected from each patient by the nursing staff who are experienced in withdrawing blood. Patients will be divided into quartiles of Hgb. Cases will be those patients whose Hgb is in the upper quartile, while controls will be those patients whose Hgb is in the lower 3 quartiles. We will be comparing visual EBL (estimated blood loss) by standard clinical assessment versus the QBL result from the device between cases and controls.
The Triton L\&D (labor and delivery) system which comprises of the device, software analysis and staff training will be supplied by the manufacturer free of charge. Research staff will be trained by the manufacturer. We will be offering our skills, fellows, midwifes and residents, who will be collecting data and we will be performing the data analysis. Results will be available to the manufacturer after results are completed. The results of this study will be presented in conferences or published in a peer-review journal.
Demographic information will be obtained from the electronic medical record. The data will be kept on a password secured University of Texas Medical Branch (UTMB) computer. An encrypted USB flash drive will be used to transfer data. The data will be identified and linked to the patient using the medical record number. During data analysis, all patient identifiers will be deleted.
Detailed description
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally (1). An estimated blood loss (EBL) in excess of 500 mL following a vaginal birth has often been used for the definition of PPH, but the average volume of blood lost at delivery can approach these amounts when actually measured rather than estimated (2). More than half of all maternal deaths occur within 24 hours of delivery, most commonly from excessive bleeding (3). Worldwide, 140,000 women succumb to postpartum hemorrhage each year. The most common antecedents to postpartum hemorrhage are uterine atony, placental disorders, and trauma during delivery. Improving maternal health worldwide is one of the WHO's 8 Millennium Developmental Goals. The prevention and treatment of PPH is an essential step towards the achievement of that goal (4).
Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation (5). Traditionally, the clinicians performing the vaginal delivery would estimate the blood loss by visually assessing the blood collected in the delivery drape drain and counting the number of lap sponges used thru out the delivery. Current detection and management of hemorrhage is heavily based on clinical judgment, which often leads to delay in recognition and intervention. Often, interventions such as fluid resuscitation and blood transfusion are not initiated until significant hemorrhage has already taken place. The traditional method for estimating blood loss is based on the clinician and nursing staff's subjective assessment that is severely limited by human error and the presence of large volumes of amniotic fluid (6).
Early detection and treatment of this potentially life-threatening obstetric complication is of utmost importance in the field of obstetrics. Simulations and didactic training have been shown to improve visual estimations, but there are still poor associations between experience level and accuracy, and a significant decay in blood loss estimation skills over time (7).
The Triton L\&D system (Gauss Surgical, Inc., Menlo Park, CA) is an FDA-cleared mobile application on a tablet computer (iPad) that facilitates quantification of blood loss (QBL) by providing an easy to use process and user interface. Dry weights of all potential blood containing substrates are built-in to the device allowing batch weighing with automatic subtraction of dry weights. There is also a V-drape simulator accounting for collected fluids with automatic subtraction of a measured amount of amniotic fluid.
QBL is not regularly used at UTMB. Although widely recommended, little data is available to support its use in the obstetrical population. We believe that gathering further evidence regarding its value is appropriate.
Our hypothesis is that use of this device for QBL will enable clinicians to objectively measure blood loss in real-time.
This study will be a prospective cohort study, in which we will evaluate two methods of evaluating blood loss during vaginal delivery (usual visual EBL assessment versus Device QBL). Of note, the subjects consented will be used as self-controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having vaginal delivery | Experimental | Device: Triton L and D system for estimation of blood loss at time of vaginal deliveryEBL will be estimated visually vs quantitatively at time of vaginal delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Triton L and D system for estimation of blood loss at time of vaginal deliveryThe Triton L\&D system (Gauss Surgical, Inc., Menlo Park, CA) is an FDA-cleared mobile application on a tablet computer (iPad) that facilitates quantification of blood loss (QBL) by providing an easy to use process and user interface. Dry weights of all potential blood containing substrates are built-in to the device allowing batch weighing with automatic subtraction of dry weights. There is also a V-drape simulator accounting for collected fluids with automatic subtraction of a measured amount of amniotic fluid. | Device | Patients having vaginal delivery |
Primary outcome
Differences in Blood Loss Between Cases and Controls Using Clinical Estimate (Visual EBL) Versus Device Assessment (QBL).
Time frame: At time of vaginal delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Antonio Saad, MD study director
UTMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triton L and D system for estimation of blood loss at time of vaginal delivery in people with Post Partum Hemorrhage and Blood Loss, run by The University of Texas Medical Branch, Galveston 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?
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: stopped early, as of the sponsor's last update on 18 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Blood Loss Between Cases and Controls Using Clinical Estimate (Visual EBL) Versus Device Assessment (QBL). (time frame: At time of vaginal delivery). 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 18 Jun 2023.