Authorised Therapeutic use (Phase IV) Women who delivered by caesarean and have a moderate postpartum iron deficiency anaemia defined by 8.0 g/dL ≤ postoperative Hb level ≤ 10.0 g/dL within 72h after delivery and a ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% (Measured after postoperative Hb level measurement)

Treatment of anaemia after caesarean with intravenous versus oral iron and postpartum depression: a multicentric randomized open-labelled controlled trial (IRON-DEP)

EU CTIS ID: 2023-503283-17-00

What this study is testing

To assess the effect of IV iron versus oral iron treatment on the prevalence of postpartum depression at 8 weeks postpartum, in women with moderate iron deficiency anaemia after caesarean delivery.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Pre-inclusion criteria: - Age ≥18 years
  • Pre-inclusion criteria: - Caesarean delivery (elective or in emergency)
  • Pre-inclusion criteria: - Gestational age at delivery ≥ 32 weeks
  • Pre-inclusion criteria: - 8.0 g/dL ≤ postoperative Hb level ≤ 10.0 g/dL measured within 72 hours postpartum
  • Pre-inclusion criteria: - Informed consent form signed
  • Pre-inclusion criteria: - Hospitalization in the postpartum maternity ward

You likely can't join if

  • - Stillbirth or neonatal death
  • - 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 known to increase the occurrence of thrombo-embolic complications (reported as a potential adverse events in the protocol of the other trial) within 2 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.
See the full eligibility criteria
Who can join
  • Pre-inclusion criteria: - Age ≥18 years
  • Pre-inclusion criteria: - Caesarean delivery (elective or in emergency)
  • Pre-inclusion criteria: - Gestational age at delivery ≥ 32 weeks
  • Pre-inclusion criteria: - 8.0 g/dL ≤ postoperative Hb level ≤ 10.0 g/dL measured within 72 hours postpartum
  • Pre-inclusion criteria: - Informed consent form signed
  • Pre-inclusion criteria: - Hospitalization in the postpartum maternity ward
  • Pre-inclusion criteria: - National social security coverage including AME
  • Inclusion criteria: - Ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement
  • Inclusion criteria: - EPDS score in the immediate postpartum <11 with a “never” answer to question n°10
What rules you out
  • - Stillbirth or neonatal death
  • - 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 known to increase the occurrence of thrombo-embolic complications (reported as a potential adverse events in the protocol of the other trial) within 2 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)
  • 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)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.