Postpartum HemorrhageNCT05046964
The PPHgb Study: Non-Invasive Hemoglobin Measurement
An observational study of Postpartum Hemorrhage, run by George Washington University at 1 site in United States.
Trial summary
This project is a prospective observational study aimed to assess the use of non-invasive hemoglobin measurement in anticipating postpartum hemorrhage and predicting estimated blood loss. The non-invasive hemoglobin device is the Radical-7 Pulse CO-Oximeter which is a spectrophotometer manufactured by Masimo, Inc. 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
- Postpartum Hemorrhage
- What is being tested?
- Masimo Radical-7 Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 5 May 2023
- 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
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between the age of 18 - 50 years old
Who may be able to join
- Pregnant women age 18 - 50 years old
- Patients scheduled for cesarean delivery at >34 weeks gestation
- Patients who failed trial of labor and require cesarean delivery
Who cannot join
- Patients with spontaneous or operative vaginal delivery
- Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)
- Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit
- Patients with hyperbilirubinemia
Trial locations and contacts
1 site in 1 country.
United States1 site
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Correlation of Non-invasive Hemoglobin Measurement With Bleeding During Cesarean Delivery: The PPHgb Study
This project is a prospective observational study aimed to assess the use of non-invasive hemoglobin measurement in anticipating postpartum hemorrhage and predicting estimated blood loss. The non-invasive hemoglobin device is the Radical-7 Pulse CO-Oximeter which is a spectrophotometer manufactured by Masimo, Inc. Participants in the study will be undergoing a cesarean delivery at the George Washington University Hospital and during delivery the patient will wear the device on their fingertip so that hemoglobin measurements can be continuously recorded. No changes from routine medical management will occur during the study.
Read the detailed description
This project is a prospective, observational study aimed to predict bleeding using hemoglobin trends measured non-invasively in patients undergoing elective cesarean delivery at the George Washington University Hospital.
The primary outcome is trend in hemoglobin measurement, at which additional interventions are required to control hemorrhage. The overall goal is to be able to determine a threshold point in which a drop in the hemoglobin level indicates severe bleeding in anticipation of postpartum hemorrhage. Through the observation of the continuous monitoring of hemoglobin across all participants and correlating those with severe hemorrhage to the magnitude of drop or time of drop, this could potentially optimize the hemorrhage protocol and might limit the need for blood transfusion and decrease maternal mortality and morbidity.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Masimo Radical-7 Pulse CO-Oximeter
- Keywords
- hemoglobin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7 Pulse CO-OximeterDevice
The Radical-7 Pulse CO-Oximeter uses photospectroscopy to non-invasively measure the total hemoglobin (SpHb) in a patient's blood throughout their C-section.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the critical threshold of SpHb drop during cesarean delivery
Measured: At the time of surgery
Correlation of the time a SpHb drop occurs with the time of hemorrhagic intervention decision
Hemorrhagic interventions include: uterotonic drugs, surgical suturing, uterine tamponade devices, blood transfusion, etc.
Measured: At the time of surgery
Secondary outcomes (1)
Correlation of the change in SpHb from pre-delivery to post-delivery values and the reported estimated blood loss or change in laboratory blood hemoglobin values.
Measured: Within 72 hours before surgery and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start2 Nov 2020
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclyn Phillips, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046964
- Sponsor's protocol ID
- NCR191913
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only aggregate de-identified information will be disclosed for this study
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Non-invasive Hemoglobin Measurement With Bleeding During Cesarean Delivery: The PPHgb Study
- ClinicalTrials.gov ID
- NCT05046964
- Acronym / sponsor ID
- NCR191913
- Conditions
- Postpartum Hemorrhage
- Keywords
- hemoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 16 Sep 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.
This project is a prospective observational study aimed to assess the use of non-invasive hemoglobin measurement in anticipating postpartum hemorrhage and predicting estimated blood loss. The non-invasive hemoglobin device is the Radical-7 Pulse CO-Oximeter which is a spectrophotometer manufactured by Masimo, Inc. Participants in the study will be undergoing a cesarean delivery at the George Washington University Hospital and during delivery the patient will wear the device on their fingertip so that hemoglobin measurements can be continuously recorded. No changes from routine medical management will occur during the study.
Detailed description
This project is a prospective, observational study aimed to predict bleeding using hemoglobin trends measured non-invasively in patients undergoing elective cesarean delivery at the George Washington University Hospital.
The primary outcome is trend in hemoglobin measurement, at which additional interventions are required to control hemorrhage. The overall goal is to be able to determine a threshold point in which a drop in the hemoglobin level indicates severe bleeding in anticipation of postpartum hemorrhage. Through the observation of the continuous monitoring of hemoglobin across all participants and correlating those with severe hemorrhage to the magnitude of drop or time of drop, this could potentially optimize the hemorrhage protocol and might limit the need for blood transfusion and decrease maternal mortality and morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between the age of 18 - 50 years old
Key inclusion criteria (3 listed)
- Pregnant women age 18 - 50 years old
- Patients scheduled for cesarean delivery at >34 weeks gestation
- Patients who failed trial of labor and require cesarean delivery
Key exclusion criteria (4 listed)
- Patients with spontaneous or operative vaginal delivery
- Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)
- Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit
- Patients with hyperbilirubinemia
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 Radical-7 Pulse CO-OximeterThe Radical-7 Pulse CO-Oximeter uses photospectroscopy to non-invasively measure the total hemoglobin (SpHb) in a patient's blood throughout their C-section. | Device | – |
Primary outcome
Determine the critical threshold of SpHb drop during cesarean delivery
Time frame: At the time of surgery
Correlation of the time a SpHb drop occurs with the time of hemorrhagic intervention decision
Time frame: At the time of surgery
Hemorrhagic interventions include: uterotonic drugs, surgical suturing, uterine tamponade devices, blood transfusion, etc.
1 secondary outcome
Correlation of the change in SpHb from pre-delivery to post-delivery values and the reported estimated blood loss or change in laboratory blood hemoglobin values.
Time frame: Within 72 hours before surgery and 24 hours after surgery
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 8 Oct 2024.
- Individual participant dataSharing planned: No. Only aggregate de-identified information will be disclosed for this study
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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 Postpartum Hemorrhage, run by George Washington University 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 3 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 8 Oct 2024. 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?
Determine the critical threshold of SpHb drop during cesarean delivery (time frame: At the time of surgery). 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 8 Oct 2024.