Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression: a Multicentric Randomized Open-labelled Controlled Trial
Assistance Publique - Hôpitaux de Paris
2,860 participants
Oct 22, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- Age ≥18 years
- Caesarean delivery (elective or in emergency)
- Gestational age at delivery ≥ 32 weeks
- 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
- 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
Exclusion Criteria19
- 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)
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Interventions
Single dose of Ferric carboxymaltose 1000 mg (20mL) IV infusion (20ml vial of 1000mg iron or two 10ml vials of 500mg)
100 mg once a day (2 pills of TIMOFÉROL® 50mg)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06833788