Clinical trial NCT04228627: Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial
Official title: Ferritin Screening And IRon Treatment for Maternal Anemia and Fetal Growth Restriction (FGR) Prevention - a Multi Centre Randomised Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Iron Deficiency (Without Anemia)
Pregnancy Related
Keywords: anemia, ferritin
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
Collaborators: name: Allama Iqbal Medical College
name: Universidad de Granada
name: Fatima Jinnah Medical University
First posted: 2020-01-14
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi centre randomised trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Non-anaemic iron deficiency

Exclusion Criteria:

* Anaemia or normal iron stores

Primary outcomes:
measure: Maternal anaemia
timeFrame: 36 weeks' gestation
Secondary outcomes:
measure: Fetal growth restriction
timeFrame: At birth
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima Jinnah Medical University
state: Punjab
city: Lahore
country: Pakistan
facility: TAYYIBA Wasim
state: Punjab
city: Lahore
country: Pakistan
facility: Allama Iqbal Medical College
state: Punjab
Study officials:
affiliation: Services Institute of Medical Sciences, Pakistan
name: TAYYIBA Wasim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.