Pregnancy AnemiaNCT06521840
Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
An observational study of Pregnancy Anemia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. Anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy Anemia
- What is being tested?
- Masimo RAD 67
- Type of treatment
- Medical device
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Sep 2025
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant patients seeking prenatal care and pregnant patients admitted to the hospital for labor admission
Who may be able to join
- Pregnant or postpartum;
- Age ≥18 years old;
- Undergoing phlebotomy for clinical purpose
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. Anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. Currently, it is recommended to screen for anemia at three pre-specified points during routine prenatal care, typically 3 months apart. This screening method may miss patients who develop anemia between these intervals and lead to a delay in diagnosis and treatment.
MasimoTM has developed a non-invasive device that can detect anemia without a blood draw. This device has not been extensively studied in pregnant patients. The aim of this study is to determine the agreement in hemoglobin readings between the non-invasive device and the standard of care blood draws in pregnant patients.
Read the detailed description
This is a prospective observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. The device is FDA approved for use in adults, children, and neonates. The current standard of care for anemia screening during pregnancy involves performing invasive venipuncture at two separate visits throughout the course of the pregnancy. The purpose of this research study is to compare the device performance with the gold standard hemoglobin measurement (venipuncture) when patients receive routine hemoglobin measurement during the course of their prenatal care.
The research team will approach pregnant patients who are presenting for prenatal care at Beth Israel Deaconess Medical Center, including the Labor and Delivery Triage Unit. The research team also will approach patients during an antepartum or postpartum admission.
The research team will use the Masimo Rad-67 handheld co-oximeter which has a reusable finger-tip sensor that enables spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin measurement. Study personnel will receive training on proper device use and cleaning by the local Masimo support team.
At the time of a blood draw, the research team will place the pulse oximeter on the participant's finger. The devices requires 1-3 minutes for an accurate measurement.
After the measurement is complete, the participant will be asked 2 questions on their satisfaction and comfortability with the device and 1 question regarding their skin tone using a validated skin tone scale.
- Conditions
- Pregnancy Anemia
- Being tested
- Masimo RAD 67
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo RAD 67Device
This is an observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. The current standard of care for anemia screening during pregnancy involves performing invasive venipuncture at two separate visits throughout the course of the pregnancy. The purpose of this research study is to compare the device performance with the gold standard hemoglobin measurement (venipuncture). The research team will use the Masimo Rad-67 handheld co-oximeter which has a reusable finger-tip sensor that enables spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin measurement. At the time of a blood draw, the research team will place the pulse oximeter on the participant's finger. The devices requires 1-3 minutes for an accurate measurement. After the measurement is complete, the participant will be asked 2 questions on their satisfaction and comfortability with the device and 1 question regarding their skin tone.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (g /dL) Accuracy of Masimo RAD 67
Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time.
Measured: At time of phlebotomy
Secondary outcomes (2)
Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by skin tone
Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time stratified by skin color using a validated scale. Monk, Ellis. "The monk skin tone scale." (2019))
Measured: At time of phlebotomy
Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by gestational age
Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time stratified by gestational age.
Measured: At time of phlebotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Dec 2024
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy AnemiaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethan Litman, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521840
- Sponsor's protocol ID
- 2024P000128
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
- ClinicalTrials.gov ID
- NCT06521840
- Acronym / sponsor ID
- 2024P000128
- Conditions
- Pregnancy Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 26 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.
Anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. Anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. Currently, it is recommended to screen for anemia at three pre-specified points during routine prenatal care, typically 3 months apart. This screening method may miss patients who develop anemia between these intervals and lead to a delay in diagnosis and treatment.
MasimoTM has developed a non-invasive device that can detect anemia without a blood draw. This device has not been extensively studied in pregnant patients. The aim of this study is to determine the agreement in hemoglobin readings between the non-invasive device and the standard of care blood draws in pregnant patients.
Detailed description
This is a prospective observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. The device is FDA approved for use in adults, children, and neonates. The current standard of care for anemia screening during pregnancy involves performing invasive venipuncture at two separate visits throughout the course of the pregnancy. The purpose of this research study is to compare the device performance with the gold standard hemoglobin measurement (venipuncture) when patients receive routine hemoglobin measurement during the course of their prenatal care.
The research team will approach pregnant patients who are presenting for prenatal care at Beth Israel Deaconess Medical Center, including the Labor and Delivery Triage Unit. The research team also will approach patients during an antepartum or postpartum admission.
The research team will use the Masimo Rad-67 handheld co-oximeter which has a reusable finger-tip sensor that enables spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin measurement. Study personnel will receive training on proper device use and cleaning by the local Masimo support team.
At the time of a blood draw, the research team will place the pulse oximeter on the participant's finger. The devices requires 1-3 minutes for an accurate measurement.
After the measurement is complete, the participant will be asked 2 questions on their satisfaction and comfortability with the device and 1 question regarding their skin tone using a validated skin tone scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant patients seeking prenatal care and pregnant patients admitted to the hospital for labor admission
Key inclusion criteria (3 listed)
- Pregnant or postpartum;
- Age ≥18 years old;
- Undergoing phlebotomy for clinical purpose
Key exclusion criteria (1 listed)
- None
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 RAD 67This is an observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. The current standard of care for anemia screening during pregnancy involves performing invasive venipuncture at two separate visits throughout the course of the pregnancy. The purpose of this research study is to compare the device performance with the gold standard hemoglobin measurement (venipuncture). The research team will use the Masimo Rad-67 handheld co-oximeter which has a reusable finger-tip sensor that enables spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin measurement. At the time of a blood draw, the research team will place the pulse oximeter on the participant's finger. The devices requires 1-3 minutes for an accurate measurement. After the measurement is complete, the participant will be asked 2 questions on their satisfaction and comfortability with the device and 1 question regarding their skin tone. | Device | – |
Primary outcome
Hemoglobin (g /dL) Accuracy of Masimo RAD 67
Time frame: At time of phlebotomy
Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time.
2 secondary outcomes
Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by skin tone
Time frame: At time of phlebotomy
Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by gestational age
Time frame: At time of phlebotomy
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 9 Mar 2026.
- 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.
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 Pregnancy Anemia, run by Beth Israel Deaconess Medical Center 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 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: finished, as of the sponsor's last update on 9 Mar 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?
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?
Hemoglobin (g /dL) Accuracy of Masimo RAD 67 (time frame: At time of phlebotomy). 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 9 Mar 2026.