Treatment of Iron Deficiency Anaemia in Pregnancy Study

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.

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Key information

Conditions

Anemia, Iron Deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

New Cross Hospital

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant women (any stage during pregnancy up to 36 weeks) and women in the puerperium (within 6 weeks postdelivery) with anaemia as defined by World Health Organization (WHO) criteria and described in British Society Haematology (BSH)/ British Committee for standards in Haematology (BCSH) guidelines.

First trimester < 110g/l
Second and third trimester < 105g/l
Puerperium < 100g/l
Age: 18-45 years
Agreement to participate in the study with consenting

Exclusion criteria

Anaemic women presenting at or after 36 weeks as there may be insufficient time to delivery to assess responses to oral iron)
Anaemic women affected by a (major) haemoglobinopathy e.g. B thalassaemia major sickle cell disease
Women with overt clinical signs of sepsis
Allergies to iron
Hyperemesis Gravidarum / persistent vomiting
Women with inflammatory conditions such as Crohns, ulcerative colitis, Systemic lupus erythematosus, Rheumatoid arthritis.
Women with chronic renal failure

Treatment and study plan

Primary outcomes

An increase in haemoglobin of at least 10g/L

Time frame: 2 to 4 weeks after the onset of iron therapy.

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Registry information

Official study title

Iron Deficiency Anaemia in Pregnancy: an Observational Study of Tolerability, Compliance With Oral Iron Therapy and Effects on Haematological/Biochemical Markers

Acronym: TIAP

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 30, 2018
Registry last updated: Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed