NCT04228627

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

January 9, 2020

Last Update Submit

January 13, 2026

Conditions

Pregnancy RelatedIron Deficiency (Without Anemia)

Keywords

anemia, ferritin

Outcome Measures

Primary Outcomes (1)

  • Maternal anaemia

    Haemoglobin concentration (g/dl)

    36 weeks' gestation

Secondary Outcomes (1)

  • Fetal growth restriction

    At birth

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Intravenous Iron to correct Iron deficiency without anaemia

Drug: Parentral Iron

Prophylaxis

NO INTERVENTION

Usual antenatal care

Interventions

Parentral IronDRUG

Correction of Iron stores without anaemia

Treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-anaemic iron deficiency

You may not qualify if:

  • Anaemia or normal iron stores

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fatima Jinnah Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

TAYYIBA Wasim

Lahore, Punjab Province, 54590, Pakistan

Location

Allama Iqbal Medical College

Lahore, Punjab Province, Pakistan

Location

Related Publications (3)

  • Pratt JJ, Khan KS. Non-anaemic iron deficiency - a disease looking for recognition of diagnosis: a systematic review. Eur J Haematol. 2016 Jun;96(6):618-28. doi: 10.1111/ejh.12645. Epub 2015 Sep 17.

    PMID: 26256281BACKGROUND

  • Wasim T, Bushra N, Tajammul A, Humayun S, Rasool S, Shahbaz F, Riaz A, Siddique F, Khawaja KI, Fatima A, Zafar Z, Khan KS. Ferritin screening and Iron treatment for maternal anemia and fetal growth restriction prevention - A multicenter randomized controlled trial (FAIR Study). Pak J Med Sci. 2023 Jan-Feb;39(1):293-299. doi: 10.12669/pjms.39.1.6686.

    PMID: 36694741BACKGROUND

  • Wasim T, Bushra N, Nasrin T, Humayun S, Tajammul A, Khawaja KI, Irshad S, Fatima S, Yasin A, Zamora J, Cano-Ibanez N, Fernandez-Felix BM, Khan KS; Ferritin screening and iron treatment for maternal anaemia and fetal growth restriction prevention (FAIR) Study Group. Intravenous iron for non-anaemic iron deficiency in pregnancy: a multicentre, two-arm, randomised controlled trial. Lancet Haematol. 2026 Jan;13(1):e22-e29. doi: 10.1016/S2352-3026(25)00315-1.

    PMID: 41482443DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemia

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • TAYYIBA Wasim

    Services Institute of Medical Sciences, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Allocation concealment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multi centre randomised trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 14, 2020

Study Start

January 14, 2020

Primary Completion

January 30, 2024

Study Completion

February 28, 2024

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
Following publication of study
Access Criteria
An acceptable IPD meta-analysis protocol with a suitable data sharing agreement

Locations

PA(3)