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Haemoglobin measurement using three different techniques in women undergoing planned vaginal birth

An agreement study comparing Masimo SpHb co-oximeter (Rad-67™ Pulse CO-Oximeter®) and HemoCue® (Hb 201+ System) with laboratory haemoglobin in women undergoing planned vaginal birth

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000247178
Enrollment
180
Registered
2019-02-19
Start date
2019-03-30
Completion date
2021-07-29
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to compare two bedside haemoglobin (Hb) measurement techniques (Rad-67™ Pulse CO-Oximeter® and HemoCue® with laboratory Hb measurements in women undergoing planned vaginal birth. Each woman will have a blood sample taken to measure Hb as part of routine care as well as a finger prick blood Hb sample (HemoCue®), and a monitor Hb measurement that is attached to the woman's finger (Rad-67™ Pulse CO-Oximeter®). The finger prick and monitor Hb measurements will be compared to the laboratory Hb sample to see if they give the same reading. The purpose of this study is to determine whether a bedside test of Hb is accurate enough to replace laboratory based Hb testing in pregnant women. The hypothesis is that these bedside tests will be able to replace laboratory Hb measurements.

Interventions

All participants will have an intravenous cannula (IVC) inserted and a venous blood sample taken as part of their routine management of labour. The timing of the IVC and venous blood sampling will be when the woman requires an IVC during her labour as part of routine management of labour. This blood will be sent to the laboratory for the laboratory haemoglobin measurement and, at the same time as the venous blood is sampled and from that same sample, one drop of blood will be used to obtain the

All participants will have an intravenous cannula (IVC) inserted and a venous blood sample taken as part of their routine management of labour. The timing of the IVC and venous blood sampling will be when the woman requires an IVC during her labour as part of routine management of labour. This blood will be sent to the laboratory for the laboratory haemoglobin measurement and, at the same time as the venous blood is sampled and from that same sample, one drop of blood will be used to obtain the Hemocue® haemoglobin sample measurement. A HemoCue® measurement of haemoglobin will also be taken at the same time via a finger prick (like a blood glucose finger prick test). At the same time blood is taken for laboratory haemoglobin measurement and Hemocue®, the finger probe of the Rad-67 continuous haemoglobin monitor will be applied to the participant finger or thumb on the same arm as the blood is taken from. The Rad-67 device obtains the haemoglobin via the placement of a finger/thumb probe that rests comfortably on a finger/thumb. The first haemoglobin reading from the Rad-67 device will be recorded as the haemoglobin result from that device. Staff taking blood samples: one of the study investigators will take the blood samples Timing of blood samples: samples will all be taken at the same time either at the start or during labour when the IVC is inserted - only one sample at one time using each method will be undertaken Location of blood samples: blood samples will all be taken from the participant's arm or hand, and the location within the hospital will be one of the acute care areas - birthing suite, emergency department, assessment centre - or wherever the participant has an IVC inserted

Sponsors

Royal Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Any women planning on having a vaginal birth including those having planned induction of labour, women who have their labour augmented and women experiencing spontaneous onset of labour.

Exclusion criteria

Women with: Abnormal haemoglobin disorders Hyperbilirubinaemia Raynaud’s or Peripheral Vascular Disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026