Treatment of anaemia after caesarean with intravenous versus oral iron and postpartum depression: a multicentric randomized open-labelled controlled trial (IRON-DEP) - APHP220806

Assistance Publique Hopitaux De Paris0 个研究点目标入组 2,860 人开始时间: 2024年1月11日最近更新: 2024年7月22日

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•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)

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