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Recruiting Phase 4

Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression

NCT06833788 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2025-10-22
Last updated
2026-09-21

Condition(s) studied

Postpartum Depression (PPD)

Investigational drug(s) / intervention(s)

Ferric carboxymaltose IV →TIMOFÉROL®

Ferric carboxymaltose IV: Single dose of Ferric carboxymaltose 1000 mg (20mL) IV infusion (20ml vial of 1000mg iron or two 10ml vials of 500mg)

TIMOFÉROL®: 100 mg once a day (2 pills of TIMOFÉROL® 50mg)

Study summary

The objectif of the IRON-DEP Study is to assess the efficacy of intravenous (IV) versus oral iron treatment on the prevalence of postpartum depression (PPD) in women with moderate iron deficiency anemia after caesarean delivery.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11 — 8 weeks postpartum
    Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire at 8 weeks. The primary measure of treatment effect will be based on the 'treatment policy' estimand: the effect will be measured by including all women who participated in the study, according to the initial randomization, regardless of the treatment they actually received or their adherence to the treatment. If the 8-week value is not observed, these participants will be included in the analysis after imputing their missing value. Secondary measures of treatment effect will be implemented based on the "principal stratum strategy" estimand: the effect will be measured in women according to the treatment they actually received and in those who achieved a compliance rate of over 80%. The estimands discussed above will be applied to all efficacy-related criteria. For safety-related criteria, only the second estimand (principal stratum strategy) will be considered.

Trial sites (1)

FacilityCityRegionStatus
CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833788 on ClinicalTrials.gov ↗ ← All trials in France