One infusion could beat daily pills for Post-Birth anemia
NCT ID NCT05590260
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether a single intravenous (IV) dose of iron works better than daily oral iron pills to treat moderate anemia in new mothers. About 4,800 women who have moderate anemia 6 to 48 hours after delivery will receive either a one-time IV iron infusion plus folic acid, or standard oral iron tablets plus folic acid for six months. The main goal is to see if more women in the IV group reach a healthy hemoglobin level by six weeks after birth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ferric carboxymaltose (IV iron) and folic acid
- What this could lead to
- If it works, this could offer a faster, more effective way to treat postpartum anemia, helping new mothers regain energy and reduce depression risk.
- What could go wrong
- This is a single trial; results may not apply to all women. IV iron carries rare risks like allergic reactions, and the benefit over oral iron may be modest.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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4,857 people
The number who actually took part.
- Started
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May 2023
- Finished
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Jul 2025
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
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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15 to 49 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Established pregnancy ≥28 weeks gestational age by last menstrual period and/or clinical assessment and/or ultrasonography * Age: 18 years (or lower limit age eligible\*) to 49 years * Confirmed moderate anemia (Hb 7.0 to 9.9 g/dL, 6-48 hour after delivery based on a venous blood sample on Hemocue®) * Deliver in participating study hospital or health facility * Able to provide informed consent * Plans to remain in study area for at least 6 months postpartum Exclusion Criteria: * IV Iron infusion received in past 3 weeks * Prior reaction to IV iron or oral iron or folic acid * Contraindication to iron supplementation (some examples may include severe allergic states including asthma, hemolytic anemia, allergy, or severe infection) * Blood transfusion already received or scheduled during the current hospital admission * Known diagnosis of pre-existing depression or other psychiatric illness * Major congenital anomaly prior to randomization * Stillbirth or neonatal loss prior to randomization * Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction * Known hemoglobinopathy (sickle cell disease or thalassemia) * Positive malaria RDT prior to randomization (sub-Saharan African sites only) * Any illness/condition requiring immediate medical care per physician's assessment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ICDDRB
Dhaka, 1212, Bangladesh
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INCAP
Guatemala City, Guatemala
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KLE Society's Jawaharlal Nehru Medical College
Belagavi, Karnataka, 590 010, India
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Kinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
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Lata Medical Research Foundation
Nagpur, India, India
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Moi University School of Medicine
Eldoret, 30100, Kenya
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The Aga Khan University
Karachi, Pakistan, 74800, Pakistan
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University Teaching Hospital
Lusaka, Zambia
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