Hemoglobin Testing for Anemia of Pregnancy
(Prosp Anemia Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test new methods for checking hemoglobin levels in pregnant women to help manage anemia. It will compare three methods: a non-invasive finger sensor, a finger prick test, and a mobile app using nailbed photos. The goal is to determine if these quick tests, including point-of-care hemoglobin testing, match the accuracy of traditional blood tests. Pregnant women without specific blood disorders or skin conditions may qualify for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance anemia management during pregnancy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these point-of-care hemoglobin testing devices are safe for use in pregnancy?
Research has shown that point-of-care hemoglobin testing devices have been studied for safety and accuracy in various settings. The Masimo device, non-invasive and clipped onto a patient's finger, is FDA approved for adults, children, and newborns, indicating its safety for these groups. The HemoCue® device, requiring a simple finger prick, is designed for anemia screening during pregnancy and provides reliable results.
Both devices are safe and effective for measuring hemoglobin. They are less invasive than traditional methods, offering more comfort and convenience for users. The Rubby app, which uses a photo of the nailbed, is a newer option that expands the range of methods tested for safe and accurate hemoglobin estimation. Overall, these point-of-care tests have shown promise in delivering quick and safe results, making them potentially useful for monitoring hemoglobin levels in pregnant patients.12345Why are researchers excited about this trial?
Point-of-care hemoglobin testing is unique because it offers a quick and convenient way to diagnose anemia in pregnant individuals right at their healthcare visit. Unlike traditional lab tests, which often require sending blood samples to a lab and waiting days for results, this method provides immediate results. This speedy testing can help healthcare providers make faster decisions about treatment, potentially improving outcomes for both the mother and baby. Researchers are excited about this trial because it could lead to more efficient anemia management during pregnancy, reducing the risk of complications associated with delayed diagnosis.
What evidence suggests that point-of-care hemoglobin testing is effective for anemia of pregnancy?
Research has shown that point-of-care hemoglobin testing accurately measures hemoglobin levels. One study compared digital devices like HemoCue to traditional methods and found them both reliable and accurate. These devices provide immediate results, aiding in more effective anemia management, especially in resource-limited areas. Anemia during pregnancy is linked to issues like early birth and low birth weight, making early detection crucial. By offering quick and easy testing, point-of-care devices may enhance anemia management and improve pregnancy outcomes.26789
Are You a Good Fit for This Trial?
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Participants are approached at their first prenatal visit (12-18 weeks of gestation) for initial hemoglobin testing using point-of-care devices
Follow-up Assessment
Participants return for a follow-up visit (24-28 weeks of gestation) for additional hemoglobin testing and comparison with traditional venipuncture
Additional Monitoring
Additional hemoglobin readings may be taken if the participant is diagnosed with anemia or requires more blood draws during prenatal care
Follow-up
Participants are monitored for safety and effectiveness after the study period
What Are the Treatments Tested in This Trial?
Interventions
- Point-of-care Hemoglobin Testing
Find a Clinic Near You
Who Is Running the Clinical Trial?
George Washington University
Lead Sponsor
Inova Health Care Services
Collaborator
Citations
Validation of Point of Care Hemoglobin Estimation Among ...
This study was aimed to assess the reliability and validity of two versions of digital hemoglobinometer (HemoCue 201+ and HemoCue 301) compared to the gold ...
2.
frontiersin.org
frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2025.1502585/fullAnemia during pregnancy and adverse pregnancy outcomes
This study aims to explore the relationship between anemia and adverse pregnancy outcomes such as preterm birth, low birth weight, and maternal mortality.
Screening for iron deficiency among pregnant women
The purpose of this study was to describe practices of screening pregnant women for ID or IDA during pregnancy and to identify the prevalence of anemia and IDA.
Use of the Electronic Health Record to Assess Prevalence ...
Overall, screening for anemia within the first 14 wk of pregnancy was high (∼92%), with most records having a measure of Hgb and Hct. Although there were ...
Emerging Point-of-Care Technologies for Anemia Detection
Optimal management of anemia requires early diagnosis and monitoring using blood tests that measure hemoglobin levels [11, 24]. Even in high resource nations, ...
Non-invasive Point-Of-Care Hemoglobin Testing In An ...
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 ...
Anemia- Hb testing during pregnancy
HemoCue® Hb301 System is optimised for anemia screening in pregnancy and brings the unique possibility to test and receive reliable results for Hb, ...
Accuracy of anemia screening by point-of-care hemoglobin ...
We sought to determine the accuracy of a capillary hemoglobin (Hb) among pregnant patients seeking induced abortion.
9.
alicantobidmc.org
alicantobidmc.org/resources/non-invasive-point-care-hemoglobin-testing-obstetric-populationNon-invasive Point-Of-Care Hemoglobin Testing In An ...
The device is FDA approved for use in adults, children, and neonates. The current standard of care for anemia screening during pregnancy ...
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