Iron infusion after C-Section may cut depression risk
NCT ID NCT06833788
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares IV iron to oral iron pills for treating moderate anemia after a C-section. The goal is to see if better iron levels can reduce the risk of postpartum depression. About 2,860 women will take part, and their mood will be checked 8 weeks after delivery.
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 Timoférol (oral iron)
- What this could lead to
- If it works, this could show that treating anemia after C-section with IV iron lowers the chance of postpartum depression.
- What could go wrong
- This is a Phase 4 trial, but it's still recruiting and results aren't in yet. The benefit may be small or not apply to all women, and IV iron carries rare risks like allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 2,860 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 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 years and older
- 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.
Pre-inclusion criteria: * Age ≥18 years * Caesarean delivery (elective or in emergency) * Gestational age at delivery ≥ 32 weeks * 8.0 g/dL ≤ postoperative Hb level ≤ 10.0 g/dL measured within 72 hours postpartum * Informed consent form signed * Hospitalization in the postpartum maternity ward * National social security coverage including AME Inclusion criteria: * Ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement * EPDS score in the immediate postpartum \<11 with a "never" answer to question n°10 Exclusion Criteria: * Stillbirth or neonatal death * Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) \< 35kg or \> 100kg * Biermer disease * Hemochromatosis * Homozygous sickle cell disease or thalassemia * Chronic iron supplementation (outside pregnancy) * Known hypersensitivity or allergy to the studied drugs (IV or oral iron) * Contra-indication to the studied drugs (IV or oral iron) * Severe asthma (with daily background treatment) * Any known severe renal or liver disorder * Active acute infection * Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation * Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders * Participation in another clinical trial involving an intervention with the following risks: * A change (increase or decrease in value) in Haemoglobin measured at 2 months postpartum OR * A change in EPDS score measured at 2 and 6 months postpartum OR * A trial exploring an intervention with a specific anaphylactic risk (reported as a potential adverse events in the protocol of the other trial) administered during the postpartum hospitalization period. * Poor understanding of the French language * Legal protection (curatorship or tutorship)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale
RECRUITINGParis, 75012, France
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Other studies related to the condition(s) this trial covers.
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- Can a wearable light device lift the fog of postpartum depression?
- Can a Three-Day pill ease postpartum depression?