Pregnancy Related Clinical Trial
— FAIROfficial title:
Ferritin Screening And IRon Treatment for Maternal Anemia and Fetal Growth Restriction (FGR) Prevention - a Multi Centre Randomised Controlled Trial (RCT)
Verified date | December 2023 |
Source | Services Institute of Medical Sciences, Pakistan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Allama Iqbal Medical College | Lahore | Punjab |
Pakistan | Fatima Jinnah Medical University | Lahore | Punjab |
Pakistan | TAYYIBA Wasim | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Services Institute of Medical Sciences, Pakistan | Allama Iqbal Medical College, Fatima Jinnah Medical University, Universidad de Granada |
Pakistan,
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
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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