FERRIC CARBOXYMALTOSE for Postpartum iron deficiency anaemia | Postpartum depression

Inclusion criteria

• {"criterion_text":"- Pre-inclusion criteria: - Age ≥18 years"}
• {"criterion_text":"- Pre-inclusion criteria: - Caesarean delivery (elective or in emergency)"}
• {"criterion_text":"- Pre-inclusion criteria: - Gestational age at delivery ≥ 32 weeks"}
• {"criterion_text":"- Pre-inclusion criteria: - 8.0 g/dL ≤ postoperative Hb level ≤ 10.0 g/dL measured within 72 hours postpartum"}
• {"criterion_text":"- Pre-inclusion criteria: - Informed consent form signed"}
• {"criterion_text":"- Pre-inclusion criteria: - Hospitalization in the postpartum maternity ward"}
• {"criterion_text":"- Pre-inclusion criteria: - National social security coverage including AME"}
• {"criterion_text":"- Inclusion criteria: - Ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement"}
• {"criterion_text":"- Inclusion criteria: - EPDS score in the immediate postpartum <11 with a “never” answer to question n°10"}

Exclusion criteria

• {"criterion_text":"- - Stillbirth or neonatal death"}
• {"criterion_text":"- - Any known severe renal or liver disorder"}
• {"criterion_text":"- - Active acute infection"}
• {"criterion_text":"- - Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation"}
• {"criterion_text":"- - Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders"}
• {"criterion_text":"- - Participation in another clinical trial involving an intervention with the following risks: •\tA change (increase or decrease in value) in Haemoglobin measured at 2 months postpartum OR •\tA change in EPDS score measured at 2 and 6 months postpartum OR •\tA 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 •\tA 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."}
• {"criterion_text":"- - Poor understanding of the French language"}
• {"criterion_text":"- - Legal protection (curatorship or tutorship)"}
• {"criterion_text":"- Body weight < 35kg or > 100kg at the end of pregnancy"}
• {"criterion_text":"- - Biermer disease"}
• {"criterion_text":"- - Hemochromatosis"}
• {"criterion_text":"- - Homozygous sickle cell disease or thalassemia"}
• {"criterion_text":"- - Chronic iron supplementation (outside pregnancy)"}
• {"criterion_text":"- - Known hypersensitivity or allergy to the studied drugs (IV or oral iron)"}
• {"criterion_text":"- - Contra-indication to the studied drugs (IV or oral iron)"}
• {"criterion_text":"- - Severe asthma (with daily background treatment)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Prevalence of PPD symptoms at 8 weeks postpartum defined as EPDS score ≥ 11 measured by the self-administered Edinburgh Postnatal Depression Scale at 8 weeks postpartum."}

Secondary endpoints

• {"endpoint_text":"- At 8 weeks postpartum • Average Hb level • Proportion of women with Hb < 12.0 g/dL • Mean serum ferritin • proportion of women with serum ferritin < 20ng/mL At inclusion and 8 weeks postpartum: Average change in Hb level between inclusion and 8 weeks postpartum","definition_or_measurement_approach":"Haematological measures at 8 weeks postpartum: mean haemoglobin, proportion with Hb <12.0 g/dL, mean serum ferritin, proportion with ferritin <20 ng/mL; and change in Hb from inclusion to 8 weeks."}
• {"endpoint_text":"- At 8 weeks postpartum • The average EPDS score • The proportion of patients presenting symptoms of moderate depression (EPDS ≥ 11 and <13) and • The proportion of patients presenting symptoms of marked depression (EPDS≥13). • The need for a transfusion of packed blood cells during the 8 weeks postpartum • The average fatigue score measured by the self-questionnaire Multidimensional Fatigue Inventory score-20 (MFI-20) overall and for each of the 5 dimensions evaluated: general fatigue, physical f","definition_or_measurement_approach":"Psychiatric and clinical measures at 8 weeks: mean EPDS score, proportions with EPDS in specified bands (≥11 and <13; ≥13), transfusion requirement within 8 weeks, MFI-20 fatigue total and dimension scores."}
• {"endpoint_text":"- At 6 months postpartum • The occurrence of long-term PPD, assessed by the proportion of women with an EPDS score ≥ 11, the average EPDS score at 6 months, the average change in the EPDS score between 8 weeks and 6 months postpartum and the proportion of women with EPDS ≥ 13 • The average fatigue score (MFI-20 score) overall and in each of its 5 dimensions, the average variation in the MFI-20 score between 8 weeks and 6 months postpartum • The bond between mother and child (average MIBS score and","definition_or_measurement_approach":"At 6 months postpartum: proportion with EPDS ≥11, mean EPDS, change from 8 weeks to 6 months, proportion with EPDS ≥13; MFI-20 mean and change; mother–child bond assessed by MIBS mean score."}
• {"endpoint_text":"- Upon administration of the product and at 8 weeks • Immune reactions (hypersensitivity reaction, bronchospasm, urticaria, flushing, itching) during IV iron administration and up to 30 minutes after stopping it • Skin pigmentation secondary to IV iron extravasation within 8 weeks of delivery At 8 weeks • Gastrointestinal side effects in the IV and oral iron groups (constipation, abdominal pain, dyspepsia, muscle cramps, nausea and vomiting) within 8 weeks postpartum","definition_or_measurement_approach":"Safety endpoints: immediate hypersensitivity and infusion-related reactions during and up to 30 minutes after IV iron; skin pigmentation due to extravasation within 8 weeks; GI adverse events within 8 weeks postpartum captured by adverse event reporting."}
• {"endpoint_text":"- At 8 weeks: Good treatment compliance is defined by taking >80% of the prescribed treatment during the 8 weeks of treatment.","definition_or_measurement_approach":"Adherence defined as taking >80% of prescribed treatment in the 8-week treatment period (assessed at 8 weeks)."}
• {"endpoint_text":"- At inclusion, 8 weeks and 6 months postpartum: Estimated total cost of healthcare use assessed by: EQ-5D-5L Postpartum hospitalizations use of outpatient care","definition_or_measurement_approach":"Health-economic endpoint assessed at inclusion, 8 weeks and 6 months using EQ-5D-5L, counts of postpartum hospitalisations and outpatient care to estimate total healthcare costs (cost-consequence analysis)."}

France

Earliest CTIS Part Ii Submission Date

26-02-2024

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

749

Number Of Sites

23

Number Of Participants

2860

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS","duties_or_roles":"Source of monetary support","organisation_type":""}