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Treatment of Iron Deficiency Anaemia in Pregnancy Study (TIAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03725150
Recruitment Status : Active, not recruiting
First Posted : October 30, 2018
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

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.

Condition or disease
Anemia, Iron Deficiency

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iron Deficiency Anaemia in Pregnancy: an Observational Study of Tolerability, Compliance With Oral Iron Therapy and Effects on Haematological/Biochemical Markers
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Pregnancy




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

Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Anaemic (iron-deficient) pregnant women.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anaemic (iron-deficient) pregnant women receiving oral iron replacement therapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725150


Locations
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United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Investigators
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Principal Investigator: David Churchill The Royal Wolverhampton NHS Trust
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Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03725150    
Other Study ID Numbers: 2018OBS100
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases