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

NCT06833788 | Not Yet Recruiting Phase 4

• 2 other identifiers: APHP2208062023-503283-17-00
• Study Type: interventional
• Target: 2,860
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression (PPD)

Keywords

Postpartum depression (PPD); Postpartum anaemia; Caesarean; Intravenous (IV) iron therapy; Oral iron therapy

Outcome Measures

Primary Outcomes (1)

• Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11

  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

Secondary Outcomes (23)

• The mean Haemoglobin (Hb) level

  8 weeks postpartum

• Change in postpartum Haemoglobin (Hb) level

  At Inclusion and at 8 weeks postpartum

• The proportion of women with Haemoglobin level < 12.0 g/dL

  8 weeks postpartum

• The mean ferritinemia level

  At Inclusion and at 8 weeks postpartum

• The mean change in ferritinemia level

  At Inclusion and at 8 weeks postpartum

Study Arms (2)

Intravenous iron

EXPERIMENTAL

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

Oral iron

ACTIVE COMPARATOR

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

Interventions

Ferric carboxymaltose IV DRUG

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

TIMOFÉROL® DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Caesarean delivery (elective or in emergency)
• Gestational age at delivery ≥ 32 weeks
• 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
• 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

You may not qualify if:

• Stillbirth or neonatal death
• Body weight \< 35kg or \> 100kg at the end of pregnancy
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale

Paris, 75012, France

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Marie-Pierre BONNET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Catherine DENEUX-THARAUX, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Marie-Pierre BONNET, MD, PhD

CONTACT

(+) 33 1 71 73 89 56; marie-pierre.bonnet@aphp.fr

Sarra POCHON, MD

CONTACT

0033 1 42 16 75 74; sarra.pochon@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

FR (1)