Which IV iron works best for anemia in pregnancy? a Head-to-Head trial
NCT ID NCT07721519
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial compares two intravenous iron treatments—ferric carboxymaltose and iron sucrose—in pregnant women with iron deficiency anemia who need IV iron. Researchers want to see which one raises hemoglobin levels more after four weeks and whether one reduces hospital visits and improves satisfaction. Four hundred women in their second or third trimester will be randomly assigned to receive either treatment, with follow-up blood tests and surveys.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intravenous ferric carboxymaltose (FCM) and intravenous iron sucrose (IS)
- What this could lead to
- If one iron treatment proves more effective, it could reduce the number of hospital visits needed and improve quality of life for pregnant women with severe anemia.
- What could go wrong
- This is a mid-sized trial in a specific population (Kurdish pregnant women), so results may not apply broadly. Both drugs carry risks like allergic reactions or infusion-site issues.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 1. Intolerance to oral iron therapy (e.g., severe nausea, severe constipation, or gastrointestinal distress). 2. 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). 3. Late presentation in the third trimester (greater than 34 weeks gestation) requiring rapid correction of anemia. 4. Moderate to severe anemia at presentation (defined as Hemoglobin less than 9.0 g/dL). Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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