Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression (IRON-DEP)

Assistance Publique - Hôpitaux de Paris

Status and phase

Not yet enrolling

Phase 4

Conditions

Postpartum Depression (PPD)

Treatments

Drug: Ferric carboxymaltose IV

Drug: TIMOFÉROL®

Study type

Interventional

Funder types

Other

Identifiers

NCT06833788

2023-503283-17-00 (EU Trial (CTIS) Number)

APHP220806

Details and patient eligibility

About

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.

Full description

PPD is a frequent (10-20% of delivery) and serious condition that has a detrimental impact on both maternal and child health by altering the quality of their interactions. Moreover, it is a significant risk factor for suicide, which is the leading cause of maternal death.

The increased risk of PPD in women with postpartum anemia has been documented. Women who delivered by cesarean are particularly vulnerable to this risk as this mode of delivery is a risk factor for both postpartum anaemia and postpartum depression. Therefore, correcting anemia and preventing PPD in this population represent a major public health priority.

First line treatment recommended for iron deficiency moderate anaemia (8.0g/dL≤ Hb ≤10.0g/dL) is oral iron. However oral iron is associated with very frequent adverse effects, contributing to poor tolerance and compliance of this treatment. Actually, IV iron is indicated in women with non-severe postpartum anaemia with lack of response or intolerance to oral iron treatment. There is growing interest in the use of intravenous iron and several randomized controlled trials demonstrated that IV iron is significantly more efficient than oral iron supplementation to correct moderate postpartum anaemia and increase haemoglobin level. However, none of them compared the efficacy of IV iron versus oral iron on postpartum depression as a primary outcome.

The hypothesis of the IRON-DEP Study is that, among women with moderate postpartum iron deficiency anaemia after caesarean delivery, the prevalence of PPD symptoms at 8 weeks after delivery is lower in women treated with IV iron than in those treated with oral iron.

The IRON-DEP trial is a phase IV national multicenter comparative randomized controlled superiority open-label trial with 2 parallel groups.

Implementation of the study :

24 french maternity units will be participating
Women who delivered by cesarean admitted in the postpartum maternity ward, with postpartum anaemia will be screened to check the inclusion and exclusion criteria.
The investigator will inform the eligible patient about the protocol and obtain the written consent
The randomization will take place during the hospitalization for caesarean delivery and will be stratified on the centre and on the initial severity of post-partum anemia (according to the postpartum hemoglobin level).
IV iron will be administered during hospitalization and participants in the oral iron group will start their treatment during their hospitalization for 8 weeks treatment.
A follow up visit at 8 weeks postpartum will be planned at the maternity unit for all participants
All participants will fill in self-assessment questionnaires (online or paper form) at inclusion, 8 weeks and 6 months postpartum follow up.

Enrollment

2,860 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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
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
- 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)