Post Partum HemorrhageAnemiaPOCNCT05977686
Hemoglobin Testing in Pregnant Patients
An observational study of Post Partum Hemorrhage and Anemia of Pregnancy, run by Inova Health Care Services at 2 sites in United States.
Trial summary
The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availability of hemoglobin… 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, Anemia of Pregnancy
- What is being tested?
- Masimo Root Radical 7 Pulse CO-Oximeter and HemoCue Hb 801
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Dec 2025to Dec 2027
- Phase
- Observational
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 ages 18-50 years old
Who may be able to join
- Pregnant women ages 18-50 years old
Who cannot join
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Inova Health System
Falls Church, Virginia, 22042
Homa Ahmadzia, MD/MPH, 703-622-6524, Homa.ahmadzia@inova.org
Study Coordinator, 7037766650, obgynresearch@inova.org
- Not yet recruiting
George Washington University
Washington D.C., District of Columbia, 20037
Jaclyn Phillips, MD, 202-741-2500, japhillips@mfa.gwu.edu
About this study
Official title: Point-Of-Care Anemia Testing in Pregnant Patients - A Prospective Observational Study
The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3) provide immediate results for real-time patient counseling and intervention. However, to date, point-of-care hemoglobin testing devices have not yet been studied for use in an ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter, manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement, and The Rubby is a mobile application based platform that uses a photo of the participants nailbed to estimate hemoglobin values. Participants in this study will be approached at the Obstetrics and Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin measurements will be assessed using the non-invasive Masimo device along with minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture hemoglobin testing.
Read the detailed description
This will be a prospective, observational study for which aim to recruit 200 patients over the study period. Patients will be approached at one of the MFA Obstetrics and Gynecology clinics. Once consented, they will be approached at least two time-points during their antenatal care as below:
- OB new/ first prenatal visit (usually between 12-18 weeks of gestation)
- OB return visit (usually between 24-28 weeks of gestation)
May need to get more Hb time-points readings (up to five readings) if the patient will be diagnosed with anemia at any of the previously mentioned visits or will be scheduled to have more blood draws during the prenatal care period. At each time-point visit, we plan to talk with the provider of the patient about the study. Then the study protocol and the recruitment process with the patient will be discussed. If the patient consents, the researchers will coordinate with the lab personnel the exact time of the routinely ordered blood draw (as a part of the subject's antenatal care) to determine the appropriate time to get the Hb readings using the devices (preferrably, right before the venipuncture). To obtain the readings, a study research coordinator will apply a disposable probe (Rainbow R1 25 adult adhesive sensor) connected to a Radical-7 co-oximeter sensor on the ring finger of the same arm of the venipuncture, shielded by an opaque covering to eliminate intereference from ambient light to obtain the SpHb reading. In addition, during in the same setting, we will ask for a finger prick capillary sample to get the Hemocue Hb reading as well (the same side will be used). Both readings will be tabulated in a case report form and the standard lab hemoglobin reading will be added to them once received. This is how it will validate the performance of the Masimo and the Hemocue devices with the routine lab test results. Additionally, the researchers will collect demographics, procedure-specific and some antenatal-care variables including vitals, gestational age and the exact date and time of the records at each time point visit, using a well-structured case report form.
- Conditions
- Post Partum Hemorrhage, Anemia of Pregnancy
- Being tested
- Masimo Root Radical 7 Pulse CO-Oximeter, HemoCue Hb 801
- 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 Root Radical 7 Pulse CO-OximeterDevice
The Masimo device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value.
HemoCue Hb 801Device
The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of each POC device to detect anemia
Sensitivity, specificity, and positive and negative predictive values for each POC device to detect anemia (Hgb < 11mg/dL) or severe anemia (Hgb < 9mg/dL).
Measured: Within 6 hours of CBC draw
To determine if Point of Care Hemoglobin testing correlates to clinical laboratory results.
Verify the correlation between point-of-care hemoglobin/ferritin values and the reference laboratory hemoglobin from a CBC (complete blood count) and clinical ferritin test. This aim will help us determine the suitability of the selected testing methods.
Measured: 24 - 48 hours to get all test results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start3 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Homa Ahmadzia, MD/MPH, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977686
- Sponsor's protocol ID
- INOVA-2024-169
- Acronym
- AnemiaPOC
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes