Blood LossNCT05012202
Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
An observational study of Blood Loss, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Blood Loss
- What is being tested?
- Hemi device
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 10 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Study population: The study population includes pregnant women admitted to the Labor \& Delivery unit for delivery.
Who may be able to join
- Pregnant women between the ages of 18-50
- Admission for vaginal delivery
- Singleton pregnancy
- Term gestation (>=37 weeks)
Who cannot join
- Pregnant women < 18 years or > 50 years
- Incarcerated patients
- Patient unwilling or unable to provide consent
- Enrolled in another trial that may affect outcome
Trial locations and contacts
1 site in 1 country.
About this study
Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. The ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose of this study is to compare the hematocrit of vaginal blood using the Hemi device with standard venipuncture.
Read the detailed description
This will be a prospective cohort study. The investigators will recruit 41 pregnant women admitted for delivery. Following delivery, a sample of vaginal blood will be collected and the Hemi device will be used to obtain hematocrit. These results will be masked to the clinical team until the time of data collection. A CBC will also be collected via venipuncture at this time. This study will be comparing hematocrit levels by standard clinical laboratory versus results from the device.
- Conditions
- Blood Loss
- Being tested
- Hemi device
- Keywords
- Vaginal delivery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemi deviceDevice
A sample of vaginal blood will be collected following delivery and analyzed by the device to provide a hematocrit level, which will be masked to the clinical team.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit
Comparison of hematocrit from vaginal blood sample versus systemic sample
Measured: During delivery
Secondary outcomes (1)
Time to obtain results
Time to obtain hematocrit level results
Measured: During delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Oct 2021
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012202
- Sponsor's protocol ID
- 21-0123
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2021
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
- ClinicalTrials.gov ID
- NCT05012202
- Acronym / sponsor ID
- 21-0123
- Conditions
- Blood Loss
- Keywords
- Vaginal delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 19 Aug 2021 (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.
Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. The ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose of this study is to compare the hematocrit of vaginal blood using the Hemi device with standard venipuncture.
Detailed description
This will be a prospective cohort study. The investigators will recruit 41 pregnant women admitted for delivery. Following delivery, a sample of vaginal blood will be collected and the Hemi device will be used to obtain hematocrit. These results will be masked to the clinical team until the time of data collection. A CBC will also be collected via venipuncture at this time. This study will be comparing hematocrit levels by standard clinical laboratory versus results from the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes pregnant women admitted to the Labor \& Delivery unit for delivery.
Key inclusion criteria (4 listed)
- Pregnant women between the ages of 18-50
- Admission for vaginal delivery
- Singleton pregnancy
- Term gestation (>=37 weeks)
Key exclusion criteria (4 listed)
- Pregnant women < 18 years or > 50 years
- Incarcerated patients
- Patient unwilling or unable to provide consent
- Enrolled in another trial that may affect outcome
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 |
|---|---|---|
| Hemi deviceA sample of vaginal blood will be collected following delivery and analyzed by the device to provide a hematocrit level, which will be masked to the clinical team. | Device | – |
Primary outcome
Hematocrit
Time frame: During delivery
Comparison of hematocrit from vaginal blood sample versus systemic sample
1 secondary outcome
Time to obtain results
Time frame: During delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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?
The sponsor lists 4 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hematocrit (time frame: During 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 17 Jul 2023.