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Hemoglobin Testing in Pregnant Patients

Study acronym: AnemiaPOC
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from Inova Health Care Services

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 2026 to Sep 2027 Show 4 more changesShow less
    • Study completion pushed from Dec 2026 to Dec 2027
    • Site contacts updated at 1 of 2 sites
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 2 words
  2. Lead sponsor: George Washington University to Inova Health Care Servicesv9 Show 4 more changesShow less
    • Primary endpoints: 4 to 2
    • Enrollment target: 200 to 250
    • Site contacts updated at 1 of 2 sites
    • Collaborators shortened, about 4 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Study completion date: Sep 2026 to Dec 2026
    • Start date changed from estimate of Oct 1, 2025 to Dec 3, 2025
    v8
  4. Collaborators expanded, about 4 wordsv7
  5. Primary and study completion dates: Sep 2025 to Sep 2026
    • Start date: Oct 1, 2024 to Oct 1, 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Apr 2024 to Oct 1, 2024v5
  2. Primary and study completion dates: Sep 2024 to Sep 2025
    • Start date: Dec 2023 to Apr 2024
    v4
  3. Start date: Sep 2023 to Dec 2023v3
  4. Study description revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05977686
Lead Sponsor Inova Health Care Services
Conditions
(from sponsor)		 Post Partum Hemorrhage, Anemia of Pregnancy
Related terms Postpartum Hemorrhage
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov