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| Name | Class |
|---|---|
| Allama Iqbal Medical College | OTHER |
| Universidad de Granada | OTHER |
| Fatima Jinnah Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Intravenous Iron to correct Iron deficiency without anaemia |
|
| Prophylaxis | No Intervention | Usual antenatal care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parentral Iron | Drug | Correction of Iron stores without anaemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal anaemia | Haemoglobin concentration (g/dl) | 36 weeks' gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal growth restriction | Birthweight for gestational age (percentile) | At birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TAYYIBA Wasim | Services Institute of Medical Sciences, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fatima Jinnah Medical University | Lahore | Punjab Province | 54000 | Pakistan | ||
| TAYYIBA Wasim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26256281 | Background | 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. | |
| 36694741 | Background | 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. |
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On completion of study we will happily discuss data sharing with any legitimate party with an IPD meta-analysis protocol.
Following publication of study
An acceptable IPD meta-analysis protocol with a suitable data sharing agreement
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
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Multi centre randomised trial
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Allocation concealment
| Lahore |
| Punjab Province |
| 54590 |
| Pakistan |
| Allama Iqbal Medical College | Lahore | Punjab Province | Pakistan |
| 41482443 | Derived | Wasim T, Bushra N, Nasrin T, Humayun S, Tajammul A, Khawaja KI, Irshad S, Fatima S, Yasin A, Zamora J, Cano-Ibanez N, Fernandez-Felix BM, Khan KS; Ferritin screening and iron treatment for maternal anaemia and fetal growth restriction prevention (FAIR) Study Group. Intravenous iron for non-anaemic iron deficiency in pregnancy: a multicentre, two-arm, randomised controlled trial. Lancet Haematol. 2026 Jan;13(1):e22-e29. doi: 10.1016/S2352-3026(25)00315-1. |
| D006425 | Hemic and Lymphatic Diseases |