A comparison between two measurement methods for total hemoglobin in Malawian pregnant women

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000219987

Acronym

REVAMP Observe

Enrollment

238

Registered

2020-02-24

Start date

2020-10-21

Completion date

2021-04-27

Last updated

2022-05-16

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

Conditions

None listed

Brief summary

Masimo has developed technology to measure total hemoglobin noninvasively (SpHb). This technology potentially offers promise in the global health context, especially in pregnancy where anemia is highly prevalent and contributes to critical outcomes including maternal mortality and low birth weight. Appropriate evaluation of SpHb in the sub-Saharan African antenatal context could provide opportunities to triage and provide appropriate care to women. This sub-study to the main REVAMP trial will be conducted to evaluate the potential of non-invasive hemoglobin measurements in pregnant women. This sub-study will recruit additional subjects that are mildly anemic and non-anemic to obtain a broad range of hemoglobin (Hb) concentrations and to examine agreement of these values with the SpHb measurements obtained by the Masimo device. These additional subjects will be the REVAMP-Observe cohort. SpHb will be compared to venous Hb at different time points across the pregnancy. The SpHb value will not be used to make any study decisions or decision regarding the clinical care of the subject.

Interventions

Women presenting to the study clinics with haemoglobin >=10g/dL will be referred for enrolment in this cohort. Participants will be recruited from second trimester of pregnancy until 12 months post partum. We will use several analysers to measure haemoglobin concentration. The test analyser is: Non-invasive - Masimo Rad-67

Eligibility

Sex/Gender

All

Healthy volunteers

Inclusion criteria

1. Confirmed singleton pregnancy at 13-26 weeks gestation 2. Mild or no anaemia (Hb >=10g/dl) 3. Negative malaria parasitaemia 4. Resident in the study catchment area of Blantyre and Zomba district 5. Plan to deliver at a health facility 6. Written informed consent (including assent if <18 years old)

Exclusion criteria

1. Any injury and/or deformity that interferes with the placement of Masimo sensors or sensor performance. 2. Any nail polish, tattoo, birthmark, etc. that interferes with sensor performance. 3. Finger size does not fit the sensor, as measured by the sensor digit gauge.

Outcome results