Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial (FAIR)

December 15, 2023 updated by: Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan

Ferritin Screening And IRon Treatment for Maternal Anemia and Fetal Growth Restriction (FGR) Prevention - a Multi Centre Randomised Controlled Trial (RCT)

Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54590
        • TAYYIBA Wasim
      • Lahore, Punjab, Pakistan
        • Allama Iqbal Medical College
      • Lahore, Punjab, Pakistan, 54000
        • Fatima Jinnah Medical University

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

Description

Inclusion Criteria:

  • Non-anaemic iron deficiency

Exclusion Criteria:

  • Anaemia or normal iron stores

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
Intravenous Iron to correct Iron deficiency without anaemia
Drug: Parentral Iron
Correction of Iron stores without anaemia
No Intervention: Prophylaxis
Usual antenatal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal anaemia
Time Frame: 36 weeks' gestation
Haemoglobin concentration (g/dl)
36 weeks' gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal growth restriction
Time Frame: At birth
Birthweight for gestational age (percentile)
At birth

Collaborators and Investigators

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

Sponsor

Services Institute of Medical Sciences, Pakistan

Collaborators

Universidad de Granada
Allama Iqbal Medical College
Fatima Jinnah Medical University

Investigators

  • Principal Investigator: TAYYIBA Wasim, Services Institute of Medical Sciences, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2020

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 11, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/2019/599/SIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On completion of study we will happily discuss data sharing with any legitimate party with an IPD meta-analysis protocol.

IPD Sharing Time Frame

Following publication of study

IPD Sharing Access Criteria

An acceptable IPD meta-analysis protocol with a suitable data sharing agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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