Treatment of anaemia after caesarean with intravenous versus oral iron and postpartum depression: a multicentric randomized open-labelled controlled trial(IRON-DEP)
- Conditions
- 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)MedDRA version: 20.0Level: SOCClassification code: 10037175Term: Psychiatric disorders Class: 7MedDRA version: 20.0Level: LLTClassification code: 10056393Term: Postpartum depression Class: 10037175Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2023-503283-17-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2860
Pre-inclusion criteria: - Age =18 years, Pre-inclusion criteria: - Caesarean delivery (elective or in emergency), Pre-inclusion criteria: - Gestational age at delivery = 32 weeks, Pre-inclusion criteria: - 8.0 g/dL = postoperative Hb level = 10.0 g/dL measured within 72 hours postpartum, Pre-inclusion criteria: - Informed consent form signed, Pre-inclusion criteria: - Hospitalization in the postpartum maternity ward, Pre-inclusion criteria: - 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, - 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 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., - Poor understanding of the French language, - Legal protection (curatorship or tutorship), 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 Objective: 1- Evaluate the effect of IV iron treatment compared to oral iron treatment on biological parameters markers of anemia, 2- Evaluate the effect of IV iron treatment compared to oral iron treatment on clinical parameters at 8 weeks postpartum, 3- Evaluate the effect of IV iron treatment compared to oral iron treatment on clinical parameters at 6 months postpartum, 4- Assess potential adverse effects of treatment, 5-Evaluation de L’observance du traitement par fer oral, 6- Medical-economic analysis with a cost-consequence approach.;Primary end point(s): 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 Outcome Measures
Name Time Method