2023-503283-17-00招募中4 期
Treatment of anaemia after caesarean with intravenous versus oral iron and postpartum depression: a multicentric randomized open-labelled controlled trial (IRON-DEP)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,860
- 试验地点
- 15
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Inclusion criteria: - Ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement
- •Inclusion criteria: - EPDS score in the immediate postpartum <11 with a “never” answer to question n°10
排除标准
- •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)
结局指标
主要结局
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.
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.
次要结局
- 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
- 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
- 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
- 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
- At 8 weeks: Good treatment compliance is defined by taking >80% of the prescribed treatment during the 8 weeks of treatment.
- 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
研究者
Pr Marie-Pierre BONNET
Scientific
Assistance Publique Hopitaux De Paris
研究点 (15)
Loading locations...
相似试验
招募中
不适用
Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)NCT07263529Istanbul University - Cerrahpasa60
尚未招募
4 期
Sucrosomial Vs Intravenous Iron for Preoperative AnemiaIron Deficiency AnemiaAnemiaNCT07287371University of Rochester75
已完成
不适用
Iron therapy for postpartum anaemia: intravenous versus oral administratioPostpartum anaemiaPregnancy and ChildbirthOther maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperiumISRCTN35112104Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)50
尚未招募
4 期
Postpartum IV Iron to Treat Iron Deficiency Anemia Post Delivery TrialHaematological DisordersPACTR202307876581314ational Institute of Child Health and Development600
已完成
3 期
Effectiveness of Oral Iron Therapy in Iron Deficiency Anemia With Daily vs Alternate Day DosingIron Deficiency AnemiaNCT07267975University of Child Health Sciences and Children's Hospital, Lahore60