Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression (NCT06833788) | Clinical Trial Compass
RecruitingPhase 4
Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
France2,860 participantsStarted 2025-10-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Haemoglob…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11