|

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

RECRUITINGPhase 4Sponsored by Assistance Publique - Hôpitaux de Paris
Actively Recruiting
PhasePhase 4
SponsorAssistance Publique - Hôpitaux de Paris
Started2025-10-22
Est. completion2028-06-22
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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 \<11 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)

Conditions2

DepressionPostpartum Depression (PPD)

Interventions2

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.