A Phase 4 interventional study of Ferric carboxymaltose IV and TIMOFÉROL® in Postpartum Depression (PPD), sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Health services research
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.
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 :
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 2,860 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pre-inclusion criteria:
Inclusion criteria:
Exclusion Criteria:
Participation in another clinical trial involving an intervention with the following risks:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women in the experimental arm will receive an IV iron infusion within 5 days after delivery
Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery
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)
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire at 8 weeks. The primary measure of treatment effect will be based on the 'treatment policy' estimand: the effect will be measured by including all women who participated in the study, according to the initial randomization, regardless of the treatment they actually received or their adherence to the treatment. If the 8-week value is not observed, these participants will be included in the analysis after imputing their missing value. Secondary measures of treatment effect will be implemented based on the "principal stratum strategy" estimand: the effect will be measured in women according to the treatment they actually received and in those who achieved a compliance rate of over 80%. The estimands discussed above will be applied to all efficacy-related criteria. For safety-related criteria, only the second estimand (principal stratum strategy) will be considered.
Time frame: 8 weeks postpartum
The mean Haemoglobin (Hb) level
All participants will have à haemoglobin measurment at 8 weeks
Time frame: 8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level
Haemoglobin measurment at 8 weeks
Time frame: At Inclusion and at 8 weeks postpartum
The proportion of women with Haemoglobin level < 12.0 g/dL
Haemoglobin measurment at 8 weeks
Time frame: 8 weeks postpartum
The mean ferritinemia level
Ferritinemia dosage at 8 weeks
Time frame: At Inclusion and at 8 weeks postpartum
The mean change in ferritinemia level
Ferritinemia dosage at 8 weeks
Time frame: At Inclusion and at 8 weeks postpartum
The proportion of women with ferritinemia < 20 ng/mL
Ferritinemia dosage at 8 weeks
Time frame: 8 weeks postpartum
Mean EPDS score
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportions of participants with moderate depressive symptoms level defined by an EPDS ≥ 11 and <13
Edinburg Postpartum Depression Scale (EPDS) will be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportions of participants with high depressive symptoms level defined by an EPDS ≥13
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean change in EPDS score
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The need for red blood cell transfusion
The variable of interest is whether (yes or no) a patient received a red blood cell transfusion. The summary measure of the effect is the percentage of patients who were transfused.
Time frame: From discharge to 8 weeks postpartum
The mean fatigue score measured by the Multidimensional Fatigue Inventory score-20 (MFI-20)
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire ( overall and in each of its 5 dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue).
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of women with high fatigue score (MIF-20 score>15)
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean relative change in MFI-20 scores
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean score for mother and child bonding measured by the Mother to Infant Bonding Scale (MIBS)
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of women with MIBS≥2
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of breastfeeding women and mean duration for those who stopped
Participants will answer self assessment questionnaires
Time frame: 8 weeks postpartum, 6 months postpartum
The mean relative change in MIBS score
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean score of quality of life measured by EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels)
EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels) overall and for each of the 5 dimensions
Time frame: 8 weeks postpartum, 6 months postpartum
The number of women in each group who also received the other group treatment within 8 weeks postpartum
Women who needed IV iron in the oral iron group because of poorly tolerated anaemia, and women who took oral iron after hospital discharge in the IV iron group
Time frame: Up to 8 weeks
Assessement of adverse events
Incidence, nature, and severity of adverse events and serious adverse events
Time frame: From first drug administration to 8 weeks
Compliance to treatment for participants in the oral iron arm
Good compliance defined by the overall drug intake \>80% of the prescribed oral iron treatment
Time frame: 8 weeks
Total costs of healthcare resources for medicoeconomic cost-consequence analysis
Use of resources and consequences for women are collected prospectively from the time of randomization up to 6 months by a a self-assessment questionnaire at 8 weeks and 6 months
Time frame: Up to 6 months postpartum
Plan to share: Yes — Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Informed consent form
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