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Trattamento dell'anemia dopo taglio cesareo con depressione per via endovenosa contro orale e postpartum (IRON-DEP)

18 settembre 2026 aggiornato da: Assistance Publique - Hôpitaux de Paris

Trattamento dell'anemia dopo un taglio cesareo con depressione endovenosa contro ferro orale e postpartum: uno studio controllato a marchio aperto multiplo

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PPD is a frequent (10-20% of delivery) and serious condition that has a detrimental impact on both maternal and child health by altering the quality of their interactions. Moreover, it is a significant risk factor for suicide, which is the leading cause of maternal death.

The increased risk of PPD in women with postpartum anemia has been documented. Women who delivered by cesarean are particularly vulnerable to this risk as this mode of delivery is a risk factor for both postpartum anaemia and postpartum depression. Therefore, correcting anemia and preventing PPD in this population represent a major public health priority.

First line treatment recommended for iron deficiency moderate anaemia (8.0g/dL≤ Hb ≤10.0g/dL) is oral iron. However oral iron is associated with very frequent adverse effects, contributing to poor tolerance and compliance of this treatment. Actually, IV iron is indicated in women with non-severe postpartum anaemia with lack of response or intolerance to oral iron treatment. There is growing interest in the use of intravenous iron and several randomized controlled trials demonstrated that IV iron is significantly more efficient than oral iron supplementation to correct moderate postpartum anaemia and increase haemoglobin level. However, none of them compared the efficacy of IV iron versus oral iron on postpartum depression as a primary outcome.

The hypothesis of the IRON-DEP Study is that, among women with moderate postpartum iron deficiency anaemia after caesarean delivery, the prevalence of PPD symptoms at 8 weeks after delivery is lower in women treated with IV iron than in those treated with oral iron.

The IRON-DEP trial is a phase IV national multicenter comparative randomized controlled superiority open-label trial with 2 parallel groups.

Implementation of the study :

  • 24 french maternity units will be participating
  • Women who delivered by cesarean admitted in the postpartum maternity ward, with postpartum anaemia will be screened to check the inclusion and exclusion criteria.
  • The investigator will inform the eligible patient about the protocol and obtain the written consent
  • The randomization will take place during the hospitalization for caesarean delivery and will be stratified on the centre and on the initial severity of post-partum anemia (according to the postpartum hemoglobin level).
  • IV iron will be administered during hospitalization and participants in the oral iron group will start their treatment during their hospitalization for 8 weeks treatment.
  • A follow up visit at 8 weeks postpartum will be planned at the maternity unit for all participants
  • All participants will fill in self-assessment questionnaires (online or paper form) at inclusion, 8 weeks and 6 months postpartum follow up.

Tipo di studio

Interventistico

Iscrizione (Stimato)

2860

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Paris, Francia, 75012
        • Reclutamento
        • CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Sperimentale: Intravenous iron

Women in the experimental arm will receive an IV iron infusion within 5 days after delivery
Comparatore attivo: Oral iron

Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
Lasso di tempo: 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.
8 weeks postpartum

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The mean Haemoglobin (Hb) level
Lasso di tempo: 8 weeks postpartum

All participants will have à haemoglobin measurment at 8 weeks
8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level
Lasso di tempo: At Inclusion and at 8 weeks postpartum

Haemoglobin measurment at 8 weeks
At Inclusion and at 8 weeks postpartum
The proportion of women with Haemoglobin level < 12.0 g/dL
Lasso di tempo: 8 weeks postpartum

Haemoglobin measurment at 8 weeks
8 weeks postpartum
The mean ferritinemia level
Lasso di tempo: At Inclusion and at 8 weeks postpartum

Ferritinemia dosage at 8 weeks
At Inclusion and at 8 weeks postpartum
The mean change in ferritinemia level
Lasso di tempo: At Inclusion and at 8 weeks postpartum

Ferritinemia dosage at 8 weeks
At Inclusion and at 8 weeks postpartum
The proportion of women with ferritinemia < 20 ng/mL
Lasso di tempo: 8 weeks postpartum

Ferritinemia dosage at 8 weeks
8 weeks postpartum
Mean EPDS score
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportions of participants with moderate depressive symptoms level defined by an EPDS ≥ 11 and <13
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) will be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportions of participants with high depressive symptoms level defined by an EPDS ≥13
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean change in EPDS score
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The need for red blood cell transfusion
Lasso di tempo: From discharge to 8 weeks postpartum

The variable of interest is whether (yes or no) a patient received a red blood cell transfusion. The summary measure of the effect is the percentage of patients who were transfused.
From discharge to 8 weeks postpartum
The mean fatigue score measured by the Multidimensional Fatigue Inventory score-20 (MFI-20)
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire ( overall and in each of its 5 dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue).
8 weeks postpartum, 6 months postpartum
The proportion of women with high fatigue score (MIF-20 score>15)
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean relative change in MFI-20 scores
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean score for mother and child bonding measured by the Mother to Infant Bonding Scale (MIBS)
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportion of women with MIBS≥2
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportion of breastfeeding women and mean duration for those who stopped
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Participants will answer self assessment questionnaires
8 weeks postpartum, 6 months postpartum
The mean relative change in MIBS score
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean score of quality of life measured by EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels)
Lasso di tempo: 8 weeks postpartum, 6 months postpartum

EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels) overall and for each of the 5 dimensions
8 weeks postpartum, 6 months postpartum
The number of women in each group who also received the other group treatment within 8 weeks postpartum
Lasso di tempo: Up to 8 weeks

Women who needed IV iron in the oral iron group because of poorly tolerated anaemia, and women who took oral iron after hospital discharge in the IV iron group
Up to 8 weeks
Assessement of adverse events
Lasso di tempo: From first drug administration to 8 weeks

Incidence, nature, and severity of adverse events and serious adverse events
From first drug administration to 8 weeks
Compliance to treatment for participants in the oral iron arm
Lasso di tempo: 8 weeks

Good compliance defined by the overall drug intake >80% of the prescribed oral iron treatment
8 weeks
Total costs of healthcare resources for medicoeconomic cost-consequence analysis
Lasso di tempo: Up to 6 months postpartum

Use of resources and consequences for women are collected prospectively from the time of randomization up to 6 months by a a self-assessment questionnaire at 8 weeks and 6 months
Up to 6 months postpartum

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigatori

  • Investigatore principale: Marie-Pierre BONNET, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Direttore dello studio: Catherine DENEUX-THARAUX, MD, PhD, Assistance Publique - Hôpitaux de Paris

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 ottobre 2025

Completamento primario (Stimato)

22 giugno 2028

Completamento dello studio (Stimato)

30 ottobre 2028

Date di iscrizione allo studio

Primo inviato

13 febbraio 2025

Primo inviato che soddisfa i criteri di controllo qualità

13 febbraio 2025

Primo Inserito (Effettivo)

19 febbraio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • APHP220806
  • 2023-503283-17-00 (Ctis)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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