NCT05977686 Hemoglobin Testing in Pregnant Patients
| NCT ID | NCT05977686 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inova Health Care Services |
| Condition | Post Partum Hemorrhage |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-12-03 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * Pregnant women ages 18-50 years old Exclusion Criteria: * 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
Contact & Investigator
Homa Ahmadzia, MD/MPH
PRINCIPAL INVESTIGATOR
Inova Health Care Services
Frequently Asked Questions
Who can join the NCT05977686 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Post Partum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05977686 currently recruiting?
Yes, NCT05977686 is actively recruiting participants. Contact the research team at japhillips@mfa.gwu.edu for enrollment information.
Where is the NCT05977686 trial being conducted?
This trial is being conducted at Washington D.C., United States, Falls Church, United States.
Who is sponsoring the NCT05977686 clinical trial?
NCT05977686 is sponsored by Inova Health Care Services. The principal investigator is Homa Ahmadzia, MD/MPH at Inova Health Care Services. The trial plans to enroll 250 participants.