MedDataX Logo

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

NCT ID: NCT04228627

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Deficiency (Without Anemia) Pregnancy Related

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

anemia, ferritin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi centre randomised trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Allocation concealment

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Intravenous Iron to correct Iron deficiency without anaemia

Group Type ACTIVE_COMPARATOR

Parentral Iron

Intervention Type DRUG

Correction of Iron stores without anaemia

Prophylaxis

Usual antenatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parentral Iron

Correction of Iron stores without anaemia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Non-anaemic iron deficiency

Exclusion Criteria

* Anaemia or normal iron stores
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allama Iqbal Medical College

OTHER

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role collaborator

Fatima Jinnah Medical University

OTHER

Sponsor Role collaborator

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tayyiba Wasim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

TAYYIBA Wasim

Role: PRINCIPAL_INVESTIGATOR

Services Institute of Medical Sciences, Pakistan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fatima Jinnah Medical University

Lahore, Punjab Province, Pakistan

Site Status

TAYYIBA Wasim

Lahore, Punjab Province, Pakistan

Site Status

Allama Iqbal Medical College

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26256281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36694741 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB/2019/599/SIMS

Identifier Type: -

Identifier Source: org_study_id