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

Pregnancy Related Clinical Trial

— FAIR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04228627
• Other study ID #: IRB/2019/599/SIMS
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: December 2023
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: February 28, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Non-anaemic iron deficiency

Exclusion Criteria:

• Anaemia or normal iron stores

Related Conditions & MeSH terms

• Anemia
• Iron Deficiency (Without Anemia)
• Pregnancy Related

Intervention

Drug:
• Parentral Iron
Correction of Iron stores without anaemia

Locations

Country	Name	City	State
Pakistan	Allama Iqbal Medical College	Lahore	Punjab
Pakistan	Fatima Jinnah Medical University	Lahore	Punjab
Pakistan	TAYYIBA Wasim	Lahore	Punjab

Sponsors (4)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan	Allama Iqbal Medical College, Fatima Jinnah Medical University, Universidad de Granada

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal anaemia	Haemoglobin concentration (g/dl)	36 weeks' gestation
Secondary	Fetal growth restriction	Birthweight for gestational age (percentile)	At birth