HemorrhageNCT03150043
Continuous Non-Invasive Measurement of Hemoglobin During Parturition
A study testing Masimo Rainbow Pulse CO-oximeter in people with Hemorrhage and Cesarean Section, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
A non-invasive hemoglobin monitor will be used during cesarean delivery and the values obtained will be compared to values obtained from traditional blood draw. 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
- Hemorrhage, Cesarean Section
- What is being tested?
- Masimo Rainbow Pulse CO-oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 9 May 2018
- 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
Who may be able to join
- Pregnant women undergoing primary cesarean delivery after failed induction of labor, or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean)
- Pregnant women between the ages of 18-50
Who cannot join
- Patient who are not pregnant
- Patients unwilling or unable to provide consent
- Patients under the age of 18
- Patients who are incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
A non-invasive hemoglobin monitor will be used during cesarean delivery and the values obtained will be compared to values obtained from traditional blood draw.
Read the detailed description
Obstetric hemorrhage remains the leading cause of maternal death worldwide (2). The most common culprits are uterine atony, placental disorders, and delivery trauma. Current detection and management of hemorrhage is heavily based on clinical judgment and laboratory results. Interventions such as fluid resuscitation and blood transfusion are often initiated after a significant hemorrhage has already taken place. Early detection and treatment of this potentially life threatening obstetric complication is of upmost importance in the field of obstetrics. Traditional methods for assessing hemoglobin levels involve collecting the patient's blood and sending it to the laboratory for analysis via complete blood count (CBC). This involves a delay and often patients are continuing to hemorrhage while the CBC is being processed. Novel technology has recently been approved by the FDA, which can continuously assess hemoglobin levels via a non-invasive monitor. This device works as a pulse oximeter, which is placed on the index finger and uses infrared technology to estimate hemoglobin levels (1). Despite its validation and use in many patient populations such as trauma, neurosurgery and orthopedic surgery, data is lacking in an obstetric population. The investigator's hypothesis is that this device will enable clinicians detect hemorrhage early and initiate resuscitation such as fluid and/or blood transfusion before significant hemorrhage has taken place. This study will be a proof of concept prospective cohort study, in which the investigators will attempt to detect the association between intra-operative and postoperative continuous non-invasive hemoglobin monitoring and postpartum decrease in hemoglobin.
Women undergoing primary cesarean delivery after failed induction of labor or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean delivery), will be eligible for participation in this study. Prior to cesarean, all patients will have a CBC drawn. Masimo non-invasive hemoglobin monitor will be placed on their finger during delivery and remain in place until discharge from the recovery room. All patients will have CBC drawn on post operative day 1, as is the standard of care at our institution. Based on the drop in hemoglobin from pre-op to post-op day 1, patients will be separated into quartiles. The quartile with the highest drop in hemoglobin will be the "cases" and compared to the remainder of the quartiles or "controls." In addition, values obtained from the non-invasive monitor will be compared to those obtained from CBC.
- Conditions
- Hemorrhage, Cesarean Section
- Being tested
- Masimo Rainbow Pulse CO-oximeter
- Keywords
- Hemoglobin, Cesarean delivery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Rainbow Pulse CO-oximeterDevice
Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles. Receives: Device: Masimo Rainbow Pulse CO-oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pearson Correlation Coefficient for Hemoglobin Measurements
Pearson Correlation Coefficient for hemoglobin measurements (Difference in Hemoglobin blood counts in g/dL between preop and post operative levels) obtained from blood draw to those obtained from the monitor
Measured: 1 day post partum
Secondary outcomes (1)
Number of Participants Who Required Blood Transfusion
The rates in percentage of patients that received transfusion of packed red blood cells.
Measured: 0-5 days post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start10 May 2017
- Primary completion9 May 2018
- Study completion9 May 2018
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 HemorrhageStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Model description
- All patients who agree to participate in the study will have the non-invasive hemoglobin monitor placed on their finger during delivery. The values obtained from the non invasive monitor will be masked to the clinicians during delivery. No medical decision making will be based on values obtained from the non-invasive monitor. After the patient leaves the recovery room, values obtained from the monitor will be compared to those obtained via blood draw. Patients will be separated into quartiles based on drop in hemoglobin (between pre-op and post-op day 1) and hemoglobin values obtained from the monitor will be compared between the quartiles.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine H Jelliffe, MD, Principal investigator, University of TexasAntonio F Saad, MD, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150043
- Sponsor's protocol ID
- 17-0087
- Status last verified
- Apr 2018
- First submitted
- 8 May 2017
- Last updated
- 24 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non-Invasive Measurement of Hemoglobin During Parturition
- ClinicalTrials.gov ID
- NCT03150043
- Acronym / sponsor ID
- 17-0087
- Conditions
- Hemorrhage, Cesarean Section
- Keywords
- Hemoglobin, Cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-invasive hemoglobin monitor will be used during cesarean delivery and the values obtained will be compared to values obtained from traditional blood draw.
Detailed description
Obstetric hemorrhage remains the leading cause of maternal death worldwide (2). The most common culprits are uterine atony, placental disorders, and delivery trauma. Current detection and management of hemorrhage is heavily based on clinical judgment and laboratory results. Interventions such as fluid resuscitation and blood transfusion are often initiated after a significant hemorrhage has already taken place. Early detection and treatment of this potentially life threatening obstetric complication is of upmost importance in the field of obstetrics. Traditional methods for assessing hemoglobin levels involve collecting the patient's blood and sending it to the laboratory for analysis via complete blood count (CBC). This involves a delay and often patients are continuing to hemorrhage while the CBC is being processed. Novel technology has recently been approved by the FDA, which can continuously assess hemoglobin levels via a non-invasive monitor. This device works as a pulse oximeter, which is placed on the index finger and uses infrared technology to estimate hemoglobin levels (1). Despite its validation and use in many patient populations such as trauma, neurosurgery and orthopedic surgery, data is lacking in an obstetric population. The investigator's hypothesis is that this device will enable clinicians detect hemorrhage early and initiate resuscitation such as fluid and/or blood transfusion before significant hemorrhage has taken place. This study will be a proof of concept prospective cohort study, in which the investigators will attempt to detect the association between intra-operative and postoperative continuous non-invasive hemoglobin monitoring and postpartum decrease in hemoglobin.
Women undergoing primary cesarean delivery after failed induction of labor or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean delivery), will be eligible for participation in this study. Prior to cesarean, all patients will have a CBC drawn. Masimo non-invasive hemoglobin monitor will be placed on their finger during delivery and remain in place until discharge from the recovery room. All patients will have CBC drawn on post operative day 1, as is the standard of care at our institution. Based on the drop in hemoglobin from pre-op to post-op day 1, patients will be separated into quartiles. The quartile with the highest drop in hemoglobin will be the "cases" and compared to the remainder of the quartiles or "controls." In addition, values obtained from the non-invasive monitor will be compared to those obtained from CBC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients who agree to participate in the study will have the non-invasive hemoglobin monitor placed on their finger during delivery. The values obtained from the non invasive monitor will be masked to the clinicians during delivery. No medical decision making will be based on values obtained from the non-invasive monitor. After the patient leaves the recovery room, values obtained from the monitor will be compared to those obtained via blood draw. Patients will be separated into quartiles based on drop in hemoglobin (between pre-op and post-op day 1) and hemoglobin values obtained from the monitor will be compared between the quartiles.
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Device: Masimo Rainbow Pulse CO-oximeterAll patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women undergoing primary cesarean delivery after failed induction of labor, or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean)
- Pregnant women between the ages of 18-50
Key exclusion criteria (4 listed)
- Patient who are not pregnant
- Patients unwilling or unable to provide consent
- Patients under the age of 18
- Patients who are incarcerated
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 |
|---|---|---|
| Masimo Rainbow Pulse CO-oximeterMasimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery | Device | All Participants |
Primary outcome
Pearson Correlation Coefficient for Hemoglobin Measurements
Time frame: 1 day post partum
Pearson Correlation Coefficient for hemoglobin measurements (Difference in Hemoglobin blood counts in g/dL between preop and post operative levels) obtained from blood draw to those obtained from the monitor
1 secondary outcome
Number of Participants Who Required Blood Transfusion
Time frame: 0-5 days post partum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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.
Katherine H Jelliffe, MD principal investigator
University of Texas
Antonio F Saad, MD study director
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masimo Rainbow Pulse CO-oximeter in people with Hemorrhage and Cesarean Section, 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 2 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 24 Feb 2021. 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 24 Feb 2021). 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?
Pearson Correlation Coefficient for Hemoglobin Measurements (time frame: 1 day post partum). 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 24 Feb 2021.