Table 1.

Characteristics of all included studies.

SN	Study ID	Study design	Details of participants	Exclusion criteria	Details of intervention	Details of comparison	Details of all outcomes	Notes
FCM verses ISC
1.	Jose et al. (15) New Delhi	Open-label RCT (2 arms) with 1:1 allocation ratio Hospital (Tertairy-care) setting Jan 2016 to Aug 2017	Pregnant women diagnosed with moderate to severe IDA (N = 100) Mean age (Mean ± SD) FCM: 27.5 ± 3.9 ISC: 26.2 ± 3.6	Anemia due to causes other than IDA Any chronic infections Raised serum transaminases & serum creatinine level Allergic to iron infusion	FCM (n = 50 → 50) Max dose of 1 g in 200 mL of 0.9% NS IV infusion for 30 min Subsequent doses (if needed) on day 7 and 14 and were rounded off nearest to 100 mg	ISC (n = 50 → 50) ISC infusion 300 mg in 200 mL NS for 15–20 min twice weekly till dosage was completed (<600 mg/ wk)	Hb (g/L) Serum ferritin (μg/L) Serum Iron (μg/dL) TIBC (μg/dL) MCV, MCH, MCHC Transferrin saturation (%) All outcomes assessed at BL, 3,6 & 12 wks	Funding status: NR Cost of drug + consumables in INR FCM: 6872.4 ± 379.7 ISC: 6566.3 ± 449.8 (p = 0.0004)
2.	Rathod et al. (28) Cuttack	Double-blind RCT (3 arms) Medical College Sept 2010 to Aug 2012	Post-partum women with IDA (N = 366) Mean age (Mean ± SD) FCM: 25.9 ± 3.57 ISC: 26.0 ± 3.66 Oral iron: 25.4 ± 3.05	Blood disorders: SCA, Thalassemia, Aplastic anemia, Megaloblastic anemia Anemia due to liver disease, kidney disease, cardiovascular disease Recent blood transfusion Allergic to parenteral iron	FCM (n = 100 → 86) Max single dose of 1 g in 250 mL 0.9% NS as drip infusion over 15 min Not more than one/week Max 0.3 mL FCM injection (15 mg iron/kg body wt.)	ISC (n = 100 → 78) ISC according to iron deficit Max dose of 300 mg elemental iron diluted in 300 mL of 0.9% NS as slow IV infusion over 30 min Repeated on alt days when necessary	Hb (g/dL) Serum ferritin (ng/mL) Adverse events Patient satisfaction All outcomes assessed at BL, 2 & 6 wks	Funding status: NR
3.	Naqash et al. (19) Jammu & Kashmir, India	Phase IV RCT (2 arms) (ISRCTN14484575) Medical College and Hospital Duration of study: May 2015 to February 2016	Female patients >18 years with IDA (N = 200) Mean Age (Mean ± SD) FCM: 30·41 ± 7·99 ISC: 27·32 ± 4·15 # of participants Pregnancy FCM/ ISC: 48/47 Post-partum FCM/ ISC: 19/20 Menorrhagia FCM/ ISC: 18/20 Others: FCM/ ISC: 15/13	Patients with Uncontrolled HTN Impaired renal, liver function Heart disease	FCM: n = 100 → 94 Max single dose of 1 g in 250 mL of 0.9% NS slow infusion for 45 min Subsequent doses on day 8 and 15	ISC: n = 100 → 93 Max dose of 200 mg diluted in 200 mL (0.9%) NS slow infusion for 30 min Rest of doses, as and when required were given on alternate days	Hb (g/dL) Serum Iron (μg/dL) Serum ferritin (μg/dL) Transferrin Saturation (%) TIBC (μg/dL) MCV (fL)All outcomes assessed at BL, 2 and 4 wks	Funding status: NR
4.	Mahey et al. (27) New Delhi	Open-label RCT (2 arms) Hospital setting Apr 2013 to May 2014 (CTRI/2015/09/006224)	Anemic patients >18 years with IDA experiencing heavy uterine bleeding (menorrhagia) (N = 60) Mean Age (Mean ± SD) FCM: 36.3 ± 9.0 ISC: 35.2 ± 7.5	Anemia with any cause other than IDA Haemochromatosis, chronic infections, gynecological malignancies, or endometrial hyperplasia Receiving myelosuppressive therapy Consuming alcohol or using illicit drugs Raised Sr. transaminase & Sr. creatinine level	FCM: n = 30 → 29 Max dose of 1 g in 200 mL of 0.9% NS over 15 min once a week	ISC: n = 30 → 29 300 mg in 200 mL 0.9% NS over 2 h twice a week	Hb (g/dL) Serum iron (μg/L) MCV (fL), MCH (pg), MCHC (g/L) All outcomes assessed at BL, 1, 6 and 12 Weeks	Funding status: NR Total per-patient costs in INR FCM: 2860.67 ± 491.8 ISC: 3298.67 ± 357.13 (p = 0.001)
5.	Patel et al. (8) Maharashtra	Prospective, RCT (2 arms) Tertiary care hospital May 2016 to April 2018	Antenatal women from 28 to 34 weeks gestation with moderate to severe anemia (N = 100) Hb levels: 6–9.9 g% Ferritin <30 ng/mL Age Between 18 to 32 years	Anemia other than IDA Hypersensitive to any iron preparation H/o bleeding tendencies Thalassemia or haemochromatosis Chronic renal failure, CVD, TB, hepatitis B, hepatitis C or HIV infection	FCM: n = 50 → 50 1 g of FCM in 200 mL 0.9% NS over 30 min	ISC: n = 50 → 50 200 mg in 100 mL 0.9% NS over 30 min on day 0, 2, 4, 6 and 8 (total 1 g)	Hb (gm%) Serum ferritin (ng/mL) Adverse reactions All outcomes assessed at BL and 3 weeks	Funding status: NR Cost of drug in INR FCM: 3310 Rs for 1 g in single dose ISC: 4050Rs fpr 1 g divided in 5 doses
6.	Dakhale et al. (29) Central India	Parallel, open label prospective study (RCT) Tertiary care hospital June 2019 to December 2020	Post-partum women with IDA (N = 60) Hb <10 g/dL Mean Age (Mean ± SD) FCM: 24.93 ± 0.59 ISC: 25.13 ± 0.69	Anemia due to other causes as aplastic, megaloblastic or haemolytic anemia Acute or chronic infection Inflammation Liver or renal disease Recent administration of IV iron preparations Blood transfusion Intolerance to iron derivatives	FCM: 30 → 30 500 mg FCM in 100 mL NS at BL	ISC: 30 → 30 200 mg dissolved In 100 mL NS 1st dose: BL 2nd dose: After 2 wks If needed, one additional dose of 100 mg was given	Hb Serum ferritin Adverse reactions All outcomes assessed at BL and 4 wks	Funding status: NR Study drugs were procured from Vinayak agency, Gandhibag, Nagpur and were given free of cost to the patients
7.	Parikh A et al. (20) Gujarat	Prospective comparative randomized analytical study (2 arms) Hospital setting September 2017 to August 2018	Pregnant women of 28–32 weeks gestation with Hb 5 to 9.5 gm% with IDA of pregnancy. (N = 100)	Anemia not caused by iron deficiency Hypersensitivity to FCM and IS. Sickle cell disease Not consenting	FCM: n = 50 → 50 Max dose 1 g in 200 mL 0.9% NS over 30 min	ISC: n = 50 →50 Total 1 g of ISC divided in 5 doses on alternate days (i.e., 200 mg) in 100 mL 0.9% NS over 15–20 min twice a week Not >600 mg/week	Hb (gm/dL) Serum Ferritin (mg/l) Adverse reaction All outcomes assessed at BL, 4 weeks and 90 days after initiation of treatment	Funding status: Funded by Emcure Pharmaceutical, Pune, India In addition 5 mg Folic acid orally once daily were given to the participants
8.	Agrawal and Masand (14) Jaipur, Rajasthan	Prospective RCT (2 arms) Hospital setting August 2018 to January 2019	Pregnant women from gestational age 20 to 36 weeks, Hb <11 gm% and serum ferritin levels <30 ng/mL (N = 100) Age between 20–40 yrs	Anaphylaxis to iron substitutes HTN Cardiac, renal, hepatic and endocrine disease Anemia due to chronic disease Worm infestation	FCM: n = 50 → 50 IV FCM (1 g/week).	ISC: n = 50 →50 IV iron sucrose 200 mg on alternate day, maximum-600 mg/week	Hb gm/dL Serum ferritin ng/mL Adverse reactions All outcomes assessed at BL and 3 weeks post infusion.	Funding status: NR
9.	Patil and Tehalia (21) India	Single-centric, parallel group, open label RCT (3 arms) Tertiary care teaching institute and research center October 2013 to June 2015	Pregnant women 24 to 34 weeks of gestation with Hb between 6.5 g/dL to <9.0 g/dL (N = 150) Age (Mean ± SD) FCM = 25.78 ± 3.68 ISC = 25.66 ± 3.45 ISr = 24.94 ± 3.3	Anemia not linked to iron deficiency, intolerance to iron derivatives H/o asthma, thromboembolism, seizures, drug abuse Renal or hepatic dysfunction.	FCM: n = 50→50 Single dose of 1 g in 100 mL NS over 15 min.	ISC: n = 50→50 200 mg/day over 20 min in 100 mL NS for 5 days (total 1 g)	Hb (g/dL) RBC count (μ/L) PCV (%) MCH (pg) MCHC (g/dL) MCV (fl) Reticulocyte count (%) Serum Ferritin (μ/L) Adverse reactions All outcomes assessed at BL, 2 and 6 weeks.	Funding status: NR
10.	Khatun and Biswas (18) Kolkata	Double arm, prospective, single center, comparative interventional RCT Medical college and Hospital setting	Pregnant women between 16–34 weeks and single viable fetus with no anomalies Age: 18 year and above IDA with Hb: 7–10 gm% Admitted in antenatal ward	Pregnant women with anemia due to causes other than IDA H/o blood transfusion, erythropoietin treatment, other medical disorders or hematological diseases Allergy to iron derivatives	FCM:n = 90 → 90 1 gm as single dose diluted in 200 mL of 0.9% NS over 30 min	ISC: n = 90 → 90 1gm divided in 4 equal doses on day l, 3, 5, 7 in 100 mL of 0.9% NS given as slow IV infusion over 30 min	Hb (g/dL) Serum ferritin Adverse reaction
11.	Sharma N et al. (30) North-eastern region	Double arm, prospective comparative study (Non-RCT) Tertiary care health center January 2015 to July 2016	Post-partum patients with Hb < 10 gm/dL. (N = 120) Mean age (Mean ± SD) FCM: 27.38 ± 4.65 ISC: 29.9 ± 5.10	Patients with anemia other than IDA. H/o blood transfusion. H/o allergy to injection iron.	FCM: n = 60 → 60 1 g in 250 mL of NS over 15 min	ISC: n = 60 → 60 200 mg in 200 mL of NS over 20–30 min every alternate day till required dose is completed. Max dose: 600 mg/week	Mean Hb (g%) Serum ferritin Adverse reaction	Funding status: NR
12.	Kaur et al. (17) Haryana	Single arm, prospective study Hospital (Subdistrict) setting Aug 2018 to Feb 2019 CTRI/2018/06/014332	Moderately and severely anemic (Hb: 5.0 and 9.9 g/dL) post-partum women within 48 h of delivery (N = 100) Age Between 18 to 35 yrs	Renal or hepatic impairment, Hb <5 g/dL Allergic to iron formulations H/o parenteral iron or blood transfusion during current pregnancy Any chronic/systemic illness Any blood disorders	FCM: n = 100 → 57 Single dose of FCM in 100 mL of 0.9% NS over 15 min under supervision of a physician within 48 h of delivery	No comparison group	1. Hb (g/dL) by digital hemoglobinometer from capillary blood 2.Serum Ferritin (ng/mL) by enhanced chemiluminescence assay from venous blood All outcomes assessed at BL, 6 wks and 6 mths	Funding status: NR Hb (Mean ± SD) BL: 8.6 ± 1.1 6 Wks: 12.5 ± 1.3 6 Mths: 12.5 ± 1.2 Serum Ferritin BL: 18.7 ± 21.0 6 Wks: 157.7 ± 145.0 6 Mths: 72 ± 52.1
13.	Kant et al. (16) Haryana	Single arm, Open-label trial Hospital (Subdistrict) setting June 2016 to Dec 2016	Pregnant females with a 16 to 32 weeks of gestation with moderate-to-severe anemia attending hospital (N = 60) Age (Mean ± SD) 23.2 ± 3.1	Renal or hepatic impairment Hb <5.0 g/dL H/o parenteral iron administration H/o blood transfusion during current pregnancy Allergic to iron preparations Thalassaemia, SCA or haemolytic anemia	FCM: n = 95→77 First follow up: n = 63 Second follow up: n = 62 Max dose of 1 g FCM in 100 mL of NS over 10–15 min	No comparison group	Hb (g/dL) Serum Ferritin (ng/mL) Adverse events All outcomes assessed at BL, 2 wks (first follow-up) and at delivery (second follow up).	Funding status: NR
FCM verses any other intervention
14.	Rathod et al. (28) Cuttack	Double-blind RCT (3 arms) Medical College Sept 2010 to Aug 2012	Post-partum women with IDA (N = 366) Mean age (Mean ± SD) FCM: 25.9 ± 3.57 ISC: 26.0 ± 3.66 Oral iron: 25.4 ± 3.05	Blood disorders: SCA, Thalassemia, Aplastic anemia, Megaloblastic anemia Anemia due to liver disease, kidney disease, cardiovascular disease Recent blood transfusion Allergic to parenteral iron	FCM (n = 114→ 100) Max single dose of 1 g in 250 mL 0.9% NS solution over 15 min Not more than one/week	Oral ferrous ascorbate (n = 100→ 70) Details not reported	Hb (g/dL) p = 0.003 Serum ferritin (ng/mL) Adverse events Patient satisfaction All outcomes assessed at BL, 2 & 6 wks	Funding status: NR
15.	Damineni et al. (31) Mangalore	Hospital-based prospective randomized comparative study (2 arms) Medical College Sept 2013 to Sept 2015	Women with peripheral smear showing microcytic hypochromic anemia (N = 90) Mean age Oral Iron: 27.4 FCM: 28.04	Anemia other than IDA Receiving myelosuppresive therapy Recent blood transfusions (within 3 months) Therapy with erythropoietin within 3 months prior to screening	FCM: n = 47 → 45 Single dose of 1 g in 250 mL of NS over 15 min	Oral ferrous ascorbate: n = 51 → 45 100 mg BD orally before meals for 6 weeks	Hb (g/dL) Adverse events Outcome assessed at BL, 1, 6 wks	Funding status: NR

IDA, Iron Deficiency Anaemia; NS, Normal Saline; Hb, Haemoglobin; TIBC, Total Iron Binding Capacity; MCV, Mean Corpuscular Volume; BL, Baseline; SCA, Sickle Cell Anaemia.