IV iron vs oral iron after cesarean for anemia and postpartum depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial compares ferric carboxymaltose IV iron with TIMOFÉROL oral iron in women with moderate postpartum iron deficiency anemia after cesarean delivery. The primary outcome is the effect on postpartum depression, with secondary considerations including anemia correction and safety. Eligible participants are adults after cesarean birth with specific iron and depressive-symptom criteria, followed in a postpartum hospital setting. The study builds on evidence that IV iron can more effectively correct anemia and may influence mood outcomes, though prior trials did not target postpartum depression as a primary endpoint. The trial is conducted under the auspices of Assistance Publique - Hôpitaux de Paris at CHU Armand-Trousseau in Paris, with no listed collaborators.

Why it matters

Who can join: the full rules

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 \<13 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)

Where it's running

• CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale
  Paris, France Recruiting

Study contacts

• Principal investigator: Marie-Pierre BONNET, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Marie-Pierre BONNET, MD, PhD
• Email: marie-pierre.bonnet@aphp.fr
• Phone: (+) 33 1 71 73 89 56

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.