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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

22 Oct 2025 → ongoing

Decision date (initial)

2024-04-05

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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.

Secondary objectives 6

1. 1- Evaluate the effect of IV iron treatment compared to oral iron treatment on biological parameters markers of anemia
2. 2- Evaluate the effect of IV iron treatment compared to oral iron treatment on clinical parameters at 8 weeks postpartum
3. 3- Evaluate the effect of IV iron treatment compared to oral iron treatment on clinical parameters at 6 months postpartum
4. 4- Assess potential adverse effects of treatment
5. 5- Evaluation de L’observance du traitement par fer oral
6. 6- Medical-economic analysis with a cost-consequence approach.

Conditions and MedDRA coding

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)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Pre-inclusion criteria: - Age ≥18 years
2. Pre-inclusion criteria: - Caesarean delivery (elective or in emergency)
3. Pre-inclusion criteria: - Gestational age at delivery ≥ 32 weeks
4. Pre-inclusion criteria: - 8.0 g/dL ≤ postoperative Hb level ≤ 10.0 g/dL measured within 72 hours postpartum
5. Pre-inclusion criteria: - Informed consent form signed
6. Pre-inclusion criteria: - Hospitalization in the postpartum maternity ward
7. Pre-inclusion criteria: - National social security coverage including AME
8. Inclusion criteria: - Ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement
9. Inclusion criteria: - EPDS score in the immediate postpartum <11 with a “never” answer to question n°10

Exclusion criteria 16

1. - Stillbirth or neonatal death
2. Body weight < 35kg or > 100kg at the end of pregnancy
3. - Biermer disease
4. - Hemochromatosis
5. - Homozygous sickle cell disease or thalassemia
6. - Chronic iron supplementation (outside pregnancy)
7. - Known hypersensitivity or allergy to the studied drugs (IV or oral iron)
8. - Contra-indication to the studied drugs (IV or oral iron)
9. - Severe asthma (with daily background treatment)
10. - Any known severe renal or liver disorder
11. - Active acute infection
12. - Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation
13. - Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders
14. - 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.
15. - Poor understanding of the French language
16. - Legal protection (curatorship or tutorship)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the prevalence of PPD symptoms at 8 weeks postpartum, defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11, measured by a self-assessment questionnaire.

Secondary endpoints 6

1. At 8 weeks postpartum • Average Hb level • Proportion of women with Hb < 12.0 g/dL • Mean serum ferritin • proportion of women with serum ferritin < 20ng/mL At inclusion and 8 weeks postpartum: Average change in Hb level between inclusion and 8 weeks postpartum
2. At 8 weeks postpartum • The average EPDS score • The proportion of patients presenting symptoms of moderate depression (EPDS ≥ 11 and <13) and • The proportion of patients presenting symptoms of marked depression (EPDS≥13). • The need for a transfusion of packed blood cells during the 8 weeks postpartum • The average fatigue score measured by the self-questionnaire Multidimensional Fatigue Inventory score-20 (MFI-20) overall and for each of the 5 dimensions evaluated: general fatigue, physical f
3. At 6 months postpartum • The occurrence of long-term PPD, assessed by the proportion of women with an EPDS score ≥ 11, the average EPDS score at 6 months, the average change in the EPDS score between 8 weeks and 6 months postpartum and the proportion of women with EPDS ≥ 13 • The average fatigue score (MFI-20 score) overall and in each of its 5 dimensions, the average variation in the MFI-20 score between 8 weeks and 6 months postpartum • The bond between mother and child (average MIBS score and
4. Upon administration of the product and at 8 weeks • Immune reactions (hypersensitivity reaction, bronchospasm, urticaria, flushing, itching) during IV iron administration and up to 30 minutes after stopping it • Skin pigmentation secondary to IV iron extravasation within 8 weeks of delivery At 8 weeks • Gastrointestinal side effects in the IV and oral iron groups (constipation, abdominal pain, dyspepsia, muscle cramps, nausea and vomiting) within 8 weeks postpartum
5. At 8 weeks: Good treatment compliance is defined by taking >80% of the prescribed treatment during the 8 weeks of treatment.
6. At inclusion, 8 weeks and 6 months postpartum: Estimated total cost of healthcare use assessed by: EQ-5D-5L Postpartum hospitalizations use of outpatient care

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Marie-Pierre BONNET

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Marie-Pierre BONNET

Locations

1 EU/EEA country · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications