Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Behandling av anemi efter kejsarsnitt med intravenöst kontra oralt järn och postpartumdepression (IRON-DEP)

18 september 2026 uppdaterad av: Assistance Publique - Hôpitaux de Paris

Behandling av anemi efter kejsarsnitt med intravenös kontra oral järn och postpartum depression: en multicentrisk randomiserad öppen märkt kontrollerad studie

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

2860

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Experimentell: Intravenous iron

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The mean Haemoglobin (Hb) level
Tidsram: 8 weeks postpartum

All participants will have à haemoglobin measurment at 8 weeks
8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level
Tidsram: 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
Tidsram: 8 weeks postpartum

Haemoglobin measurment at 8 weeks
8 weeks postpartum
The mean ferritinemia level
Tidsram: 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
Tidsram: 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
Tidsram: 8 weeks postpartum

Ferritinemia dosage at 8 weeks
8 weeks postpartum
Mean EPDS score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Utredare

  • Huvudutredare: Marie-Pierre BONNET, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Studierektor: Catherine DENEUX-THARAUX, MD, PhD, Assistance Publique - Hôpitaux de Paris

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 oktober 2025

Primärt slutförande (Beräknad)

22 juni 2028

Avslutad studie (Beräknad)

30 oktober 2028

Studieregistreringsdatum

Först inskickad

13 februari 2025

Först inskickad som uppfyllde QC-kriterierna

13 februari 2025

Första postat (Faktisk)

19 februari 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • APHP220806
  • 2023-503283-17-00 (Ctis)
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera