Hemoglobin Levels in Blood Clinical Trial
— Pronto-7Official title:
Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients
| Verified date | September 2014 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The measurement of blood hemoglobin (Hb) concentration is a routine procedure in pregnant
women. The assessment of Hb involves several steps, including a needle stick, blood
collection, blood sample analysis in the laboratory, and waiting for the results.
Pronto-7 (manufactured by Masimo, CA, USA) is a new portable device that allows a quick
bedside Hb spot check. A finger clip probe, similar to the standard oxygen finger clip probe,
provides hemoglobin values in less than 60 seconds.
In this prospective observational study the investigators will assess the clinical accuracy
of Pronto-7 derived Hb values compared to the gold standard laboratory Hb values in obstetric
patients. We will be calculating the mean difference between Pronto-7 and laboratory Hb
values. We plan to recruit 55 pregnant women admitted for vaginal or cesarean delivery at BC
Women's Hospital.
| Status | Completed |
| Enrollment | 71 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 19 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Are 19 - 40 years old - Understand written and oral English - Are greater than 37 weeks gestational age - Have a singleton pregnancy Exclusion Criteria: - Have a laboratory Hb less than 100 g/L - Have abnormal Hb disorders - Have hyperbilirubinemia - Have a peripheral vascular disease (e.g. Reynaud's syndrome) - Have long or acrylic nails |
| Country | Name | City | State |
|---|---|---|---|
| Canada | BC Women's Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia | Masimo Corporation |
Canada,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Consistency of lab Hb results | Comparison between the first and second reading on the laboratory Cooximeter. | 4 hours after venipuncture | |
| Primary | Hemoglobin (Hb) value | Difference between the pre-venipuncture SpHb values and the laboratory Hb values (SpHb-Lab Hb difference) measured from the same extremity of each subject | 15-20 minutes before venipuncture | |
| Secondary | Comparisons of SpHb values | Comparison between right and left hand SpHb values measured immediately before venipuncture. Comparison between right and left hand SpHb values measured immediately after venipuncture. Comparison of SpHb values measured from the same extremity immediately before and after venipuncture. Comparison of the SpHb-lab Hb differences between subjects in labour for vaginal delivery and subjects undergoing elective cesarean delivery. |
15-20 minutes before venipuncture and 15-20 minutes after venipuncture |