Treatment of Iron deficiency Anaemia in Pregnancy study (TIAP)

  • Research type

    Research Study

  • Full title

    Iron deficiency anaemia in pregnancy: an observational study of tolerability, compliance with oral iron therapy and effects on haematological/biochemical markers

  • IRAS ID

    244013

  • Contact name

    David Churchill

  • Contact email

    david.churchill1@nhs.net

  • Sponsor organisation

    The Royal Wolverhampton NHS Trust,

  • Duration of Study in the UK

    1 years, 6 months, 1 days

  • Research summary

    Research Summary
    The burden of anaemia remains unacceptably high during pregnancy. Over a third of women are anaemic by their third trimester of pregnancy. The most common cause is iron deficiency. One key factor is rising iron requirements throughout pregnancy. There are risks associated with anaemia for the mother and infant. Anaemia in the first and second trimester has been significantly correlated with low birth weight and pre-term birth, and is associated with impaired neurological development of the baby. It also increases the risk of intrauterine fetal death, and the likelihood of the mother requiring blood transfusions during or after delivery.

    This study is a prospective cohort study, which aims to better define the natural history and understand how to use oral iron therapy for iron deficiency anaemia in pregnant women. This includes documenting the impact of treatment on anaemia symptoms, side effects, and the level of success of iron therapy using several haematological tests. Pregnant women will be invited to participate in this study and treated using a treatment schedule as described in national guidelines.
    Additional blood samples will be taken for subsequent detailed analysis of pathways of iron metabolism to better predict the response to oral iron therapy during pregnancy.

    Summary of Results
    Pregnant women who developed anaemia were seen in a dedicated anaemia research clinic. The guidelines for the treatment of anaemia during pregnancy that were current at the time were applied with a high degree of fidelity. Regardless of how response to treatment was defined there was a high level of failure to respond to oral iron. Only a third of women showed and increase in their haemoglobin level of greater than 10 gms/L. When normalisation of haemoglobin for pregnancy was taken into account only a half of women responded to oral iron. Women that failed to respond to treatment had much higher levels of recorded side effects 15% vs5%. Women who had moderate to severe anaemia at diagnosis were more likely to respond to oral iron, with a more significant increase in their haemoglobin concentration than those with mild anaemia.

  • REC name

    West Midlands - Black Country Research Ethics Committee

  • REC reference

    18/WM/0090

  • Date of REC Opinion

    20 Apr 2018

  • REC opinion

    Further Information Favourable Opinion