The goal of this clinical trial is to compare two types of intravenous (IV) iron-Ferric Carboxymaltose (FCM) and Iron Sucrose (IS)-to learn which one works better to treat iron deficiency anemia in pregnant women who have a clear medical need for IV iron. It will also learn about the safety of both drugs. The main questions it aims to answer are:
Participants will:
Inclusion Criteria:
Parity: All parity levels accepted (Para 0, Para 1, Para 2-4, and Para 5 or more).
Pregnancy Stage: Currently in the second or third trimester of pregnancy (greater than 14 weeks gestation).
Confirmed Iron Deficiency Anemia (IDA): Documented Hemoglobin (Hb) less than 11 g/dL AND Serum Ferritin less than 30 ng/mL.
Medical Indication for Intravenous (IV) Iron: Must meet at least one of the following specific clinical indications:
Exclusion Criteria:
shahla_alaf@yahoo.com+9647504480711
The laboratory personnel responsible for processing and analyzing the primary and secondary hematological outcomes (including Hemoglobin and Serum Ferritin levels) are fully blinded to the treatment arm assignments. Additionally, the data analysts performing the statistical evaluation of both the clinical data and the maternal satisfaction surveys will remain blinded to the participant group allocations until the final database lock.
Participants assigned to this arm will receive intravenous (IV) iron sucrose (Blogen) utilizing a step-up safety protocol to minimize acute hypersensitivity risks. On Day 1 (Baseline), participants will receive an initial safety and tolerability dose of 100 mg of iron sucrose diluted in 100 mL of 0.9% Normal Saline (NS), infused intravenously over a minimum of 15 minutes. Participants will be monitored for at least 30 minutes post-infusion for acute adverse events or hypersensitivity reactions. In the absence of any safety signals or severe drug intolerance, subsequent maintenance doses will scale to 200 mg of iron sucrose diluted in 100 mL of 0.9% NS, administered via intravenous infusion over 30 minutes. This 200 mg dose will be administered twice weekly, with a strict minimum of 48 hours between consecutive administrations, to reach a total weekly dose of 400 mg, until the participant's predefined cumulative iron deficit target is achieved.
Participants assigned to this arm will receive intravenous (IV) iron sucrose (Blogen, 20 mg/mL concentration) utilizing a step-up safety sequence delivered via manual gravity drip. On Day 1 (Baseline), participants will receive an initial safety and tolerability check dose of 100 mg (5 mL) of iron sucrose diluted in 100 mL of sterile 0.9% Normal Saline (NS) and infused over a minimum of 15 minutes. Following a clinical evaluation to confirm the absence of acute hypersensitivity or infusion reactions, subsequent maintenance doses will escalate to 200 mg (10 mL) of iron sucrose. Each 200 mg maintenance dose will be diluted in 150 mL of sterile 0.9% NS, yielding a 160 mL total fluid volume with a stable iron concentration of 1.25 mg/mL (safely above the manufacturer's 1 mg/mL stability floor). The solution will be administered via an intravenous gravity drip set, with the flow rate manually calibrated and monitored by clinical staff to ensure the full volume is infused over exactly 30 mi
raqib.husei@hmu.edu.krd07504729617 ext. 00964
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women
Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women
Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)
EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCY
Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Post Partum Iron Deficiency Anaemia
Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia
Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia