Reticulocyte haemoglobin equivalent&iron deficiency in pregnancy(v1.0)
Research type
Research Study
Full title
Reticulocyte Haemoglobin Equivalent: application in the diagnosis and monitoring of iron deficiency in pregnancy
IRAS ID
148441
Contact name
Sinead Carty
Contact email
Sponsor organisation
Northern Health and Social Care Trust
Research summary
Iron is vital to production of the body’s red blood cells (RBCs.) Iron deficiency (ID) is a familiar cause of anaemia and a prevalent global problem in pregnancy. The importance of iron in pregnancy is evident by the association between ID and maternal infection, pre-term delivery, low birth weight and adverse neonatal cognitive development. It is therefore essential to prevent, diagnose and treat ID early. Current laboratory testing (such as the full blood count (FBC) and serum iron profile) for ID and related anaemia suffer limitations and a specific indicator of iron-deficient RBC production would be clinically useful.
The Sysmex XE-2100 (Kobe, Japan) is a modern haematology analyser providing a novel parameter known as the reticulocyte haemoglobin equivalent (Ret-He) that has the ability to identify early ID and assess progress of iron treatment. Application of the Ret-He parameter in pregnancy has not been widely explored, yet may minimise expense, reduce need for therapeutic iron and avert blood transfusion in cases of severe iron deficiency anaemia (IDA).
The proposed study aims to define the Ret-He normal range; determine a Ret-He value that can diagnose ID/IDA; assess Ret-He test performance; and determine the effect of iron supplementation on the Ret-He value. The research will consist of pregnant women (all trimesters) aged ≥ 16 years. Experimental approach will entail the appropriate selection of healthy and ID/IDA participants based on laboratory analysis of FBC and serum iron parameters. The Ret-He value will be determined in healthy participants, ID/IDA participants and participants with ID/IDA pre- and post-iron therapy.
The four month study will be funded by the Northern Health and Social Care Trust and conducted at associated antenatal clinics. Participants will be informed regarding the nature of the research study, their obligation to sign written consent and the requirement for an additional sample draw.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/0053
Date of REC Opinion
14 Feb 2014
REC opinion
Favourable Opinion