Treatment of Iron Deficiency Anaemia in Pregnancy Study (TIAP)

August 9, 2022 updated by: The Royal Wolverhampton Hospitals NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

    1. First trimester < 110g/l
    2. Second and third trimester < 105g/l
    3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
An increase in haemoglobin of at least 10g/L
Time Frame: 2 to 4 weeks after the onset of iron therapy.
2 to 4 weeks after the onset of iron therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Investigators

  • Principal Investigator: David Churchill, The Royal Wolverhampton NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Actual)

December 17, 2019

Study Completion (Actual)

December 17, 2019

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018OBS100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia, Iron Deficiency

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe