Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women

Starting soon · Not applicable

Conditions studied: Iron Deficiency Anemia in Pregnancy

In brief

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: 1. Does FCM lead to a higher increase in hemoglobin (blood iron) levels 4 weeks after treatment compared to IS? 2. What medical problems or side effects do women experience with each drug? 3. Does FCM reduce the number of hospital visits and improve women satisfaction? Participants will: 1. Be in their second or third trimester and share the same precise medical indications requiring IV iron (such as severe anemia, no improvement from pills, or being very late in their pregnancy). 2. Be randomly assigned from the start to receive either FCM or IS through an IV, with the total dose calculated based on their body weight and blood tests. 3. Receive FCM in one or more full doses, or receive IS split into multiple smaller sessions up to 3 times a week. 4. Visit the clinic for their assigned infusions and undergo blood tests and satisfaction surveys twice: right before starting treatment and 1 month after receiving the medication.

Key facts

Study ID

NCT07721519

Run by

Hawler Medical University

People needed

400

Starts

2026-09-01

Expected to finish

2028-12-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Intolerance to oral iron therapy (e.g., severe nausea, severe constipation, or gastrointestinal distress).
• Failure to respond to oral iron therapy (defined as a Hemoglobin increase of less than 1 g/dL after 3 weeks of compliant oral intake).
• Late presentation in the third trimester (greater than 34 weeks gestation) requiring rapid correction of anemia.
• Moderate to severe anemia at presentation (defined as Hemoglobin less than 9.0 g/dL).

You may not qualify if…

• First trimester of pregnancy (less than or equal to 14 weeks gestation).
• Known hypersensitivity, allergy, or previous severe adverse reaction to intravenous iron formulations or any of their components.
• Anemia due to causes other than iron deficiency (e.g., vitamin B12 or folate deficiency, hemoglobinopathies, anemia of chronic disease).
• Active, severe systemic infection.
• Relevant medical exclusions , such as severe hepatic or renal impairments

Full record on ClinicalTrials.gov

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