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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04228627
Other study ID # IRB/2019/599/SIMS
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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