Evaluation of a non-invasive hemoglobin and a minimally invasive ferritin point of care device for screening for anemia in pregnant women in India

Anemia remains one of the commonest problems during pregnancy in the world. The highest burden of anemia in pregnancy is in low resource settings, where measuring hemoglobin and appropriately treating anemia remains a challenge.

In settings where antenatal care is delivered at home or in small facilities, a point of care device capable of non-invasive estimation of hemoglobin could have great utility.

Point of care ferritin measurement devices when used in combination with hemoglobin measurement could help to understand whether iron deficiency is the underlying cause of anemia.

Pregnant women residing in low middle income urban resettlement neighborhood in South district of Delhi will be identified and approached for participation in the study. 450 pregnant women from all gestational ages across pregnancy (up to term prior to onset of labour) will be enrolled.

The following activities will be conducted on the day of enrolment for all pregnant women who give consent for participation:

• Collection of baseline demographic and health data
• Point of care hemoglobin estimation using EzeCheckTM non-invasive instrument
• Point of care serum ferritin estimated from capillary blood (finger-prick) using ferritin lateral flow assay device from Huwel Lifesciences, India.
• Venous blood sample collection for hemoglobin and serum ferritin estimation at a nationally accredited laboratory

Study staff will follow-up with the participants monthly to collect information on their subsequent ANC visits, treatment and any investigations advised, reports of any other investigations related to anemia, compliance to advised medication and outcome of pregnancy. Pregnancies will be tracked until delivery to identify outcomes. These outcomes will be used to estimate the benefit from

point of care tests.

The total duration of the study will be 24 months. Participation of each pregnant woman will be till ascertainment of the outcome of her pregnancy.

Qualitative analysis of stakeholder perceptions about the acceptability of non-invasive measurements and point-of-care methods and anemia management will be done through interviews and focus group discussions with pregnant women, health care personnel and physicians.

Evaluation of point of care test devices for their accuracy and error ranges for use as screening test in pregnant women will be done.

Data on the hemoglobin and ferritin levels, treatment decision, pregnancy outcomes and costs involved, that is collected at the different stages of pregnancy, will be used to build model to estimate the potential cost saving and benefits from the use of non-invasive and minimally invasive screening tests for anemia during pregnancy.