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Compares treatment options for Postpartum Depression (PPD)
Official title Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
ClinicalTrials.gov ID: NCT06833788
What this study is testing
What is Ferric carboxymaltose IV?
Ferric carboxymaltose IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postpartum depression (ppd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pre-
- 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
You likely can't join if
- Stillbirth or neonatal death
- Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) \ 100kg
- Biermer disease
- Hemochromatosis
- Homozygous sickle cell disease or thalassemia
- Chronic iron supplementation (outside pregnancy)
See the full eligibility criteria
- Pre-
- 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
- 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
- Stillbirth or neonatal death
- Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) \ 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 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)
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.