Treatment of Iron Deficiency Anaemia in Pregnancy Study

NCT03725150 | Completed

• 1 other identifier: 2018OBS100
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia, Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• An increase in haemoglobin of at least 10g/L

  2 to 4 weeks after the onset of iron therapy.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Anaemic (iron-deficient) pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Anaemic (iron-deficient) pregnant women receiving oral iron replacement therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

New Cross Hospital

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• David Churchill

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: June 19, 2018
• Primary Completion: November 11, 2019
• Study Completion: December 17, 2019
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

GB (1)