Tratamiento de anemia después de cesárea con hierro intravenoso versus oral y depresión posparto (IRON-DEP)
Tratamiento de la anemia después de la cesárea con la depresión intravenosa versus el hierro oral y la depresión posparto: un ensayo controlado abierto aleatorizado multicéntrico
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PPD is a frequent (10-20% of delivery) and serious condition that has a detrimental impact on both maternal and child health by altering the quality of their interactions. Moreover, it is a significant risk factor for suicide, which is the leading cause of maternal death.
The increased risk of PPD in women with postpartum anemia has been documented. Women who delivered by cesarean are particularly vulnerable to this risk as this mode of delivery is a risk factor for both postpartum anaemia and postpartum depression. Therefore, correcting anemia and preventing PPD in this population represent a major public health priority.
First line treatment recommended for iron deficiency moderate anaemia (8.0g/dL≤ Hb ≤10.0g/dL) is oral iron. However oral iron is associated with very frequent adverse effects, contributing to poor tolerance and compliance of this treatment. Actually, IV iron is indicated in women with non-severe postpartum anaemia with lack of response or intolerance to oral iron treatment. There is growing interest in the use of intravenous iron and several randomized controlled trials demonstrated that IV iron is significantly more efficient than oral iron supplementation to correct moderate postpartum anaemia and increase haemoglobin level. However, none of them compared the efficacy of IV iron versus oral iron on postpartum depression as a primary outcome.
The hypothesis of the IRON-DEP Study is that, among women with moderate postpartum iron deficiency anaemia after caesarean delivery, the prevalence of PPD symptoms at 8 weeks after delivery is lower in women treated with IV iron than in those treated with oral iron.
The IRON-DEP trial is a phase IV national multicenter comparative randomized controlled superiority open-label trial with 2 parallel groups.
Implementation of the study :
- 24 french maternity units will be participating
- Women who delivered by cesarean admitted in the postpartum maternity ward, with postpartum anaemia will be screened to check the inclusion and exclusion criteria.
- The investigator will inform the eligible patient about the protocol and obtain the written consent
- The randomization will take place during the hospitalization for caesarean delivery and will be stratified on the centre and on the initial severity of post-partum anemia (according to the postpartum hemoglobin level).
- IV iron will be administered during hospitalization and participants in the oral iron group will start their treatment during their hospitalization for 8 weeks treatment.
- A follow up visit at 8 weeks postpartum will be planned at the maternity unit for all participants
- All participants will fill in self-assessment questionnaires (online or paper form) at inclusion, 8 weeks and 6 months postpartum follow up.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marie-Pierre BONNET, MD, PhD
- Número de teléfono: (+) 33 1 71 73 89 56
- Correo electrónico: marie-pierre.bonnet@aphp.fr
Copia de seguridad de contactos de estudio
- Nombre: Sarra POCHON, MD
- Número de teléfono: 0033 1 42 16 75 74
- Correo electrónico: sarra.pochon@aphp.fr
Ubicaciones de estudio
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Paris, Francia, 75012
- Reclutamiento
- CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Pre-inclusion criteria:
- 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
Inclusion criteria:
- Ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement
- EPDS score in the immediate postpartum <13 with a "never" answer to question n°10
Exclusion Criteria:
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Stillbirth or neonatal death
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Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) < 35kg or > 100kg
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Biermer disease
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Hemochromatosis
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Homozygous sickle cell disease or thalassemia
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Chronic iron supplementation (outside pregnancy)
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Known hypersensitivity or allergy to the studied drugs (IV or oral iron)
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Contra-indication to the studied drugs (IV or oral iron)
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Severe asthma (with daily background treatment)
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Any known severe renal or liver disorder
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Active acute infection
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Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation
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Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders
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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.
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Poor understanding of the French language
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Legal protection (curatorship or tutorship)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
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Experimental: Intravenous iron
Women in the experimental arm will receive an IV iron infusion within 5 days after delivery |
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Comparador activo: Oral iron
Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
Periodo de tiempo: 8 weeks postpartum
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Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire at 8 weeks. The primary measure of treatment effect will be based on the 'treatment policy' estimand: the effect will be measured by including all women who participated in the study, according to the initial randomization, regardless of the treatment they actually received or their adherence to the treatment. If the 8-week value is not observed, these participants will be included in the analysis after imputing their missing value. Secondary measures of treatment effect will be implemented based on the "principal stratum strategy" estimand: the effect will be measured in women according to the treatment they actually received and in those who achieved a compliance rate of over 80%. The estimands discussed above will be applied to all efficacy-related criteria. For safety-related criteria, only the second estimand (principal stratum strategy) will be considered. |
8 weeks postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The mean Haemoglobin (Hb) level
Periodo de tiempo: 8 weeks postpartum
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All participants will have à haemoglobin measurment at 8 weeks |
8 weeks postpartum
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Change in postpartum Haemoglobin (Hb) level
Periodo de tiempo: At Inclusion and at 8 weeks postpartum
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Haemoglobin measurment at 8 weeks |
At Inclusion and at 8 weeks postpartum
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The proportion of women with Haemoglobin level < 12.0 g/dL
Periodo de tiempo: 8 weeks postpartum
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Haemoglobin measurment at 8 weeks |
8 weeks postpartum
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The mean ferritinemia level
Periodo de tiempo: At Inclusion and at 8 weeks postpartum
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Ferritinemia dosage at 8 weeks |
At Inclusion and at 8 weeks postpartum
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The mean change in ferritinemia level
Periodo de tiempo: At Inclusion and at 8 weeks postpartum
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Ferritinemia dosage at 8 weeks |
At Inclusion and at 8 weeks postpartum
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The proportion of women with ferritinemia < 20 ng/mL
Periodo de tiempo: 8 weeks postpartum
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Ferritinemia dosage at 8 weeks |
8 weeks postpartum
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Mean EPDS score
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The proportions of participants with moderate depressive symptoms level defined by an EPDS ≥ 11 and <13
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Edinburg Postpartum Depression Scale (EPDS) will be measured by a self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The proportions of participants with high depressive symptoms level defined by an EPDS ≥13
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
|
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The mean change in EPDS score
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
|
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The need for red blood cell transfusion
Periodo de tiempo: From discharge to 8 weeks postpartum
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The variable of interest is whether (yes or no) a patient received a red blood cell transfusion. The summary measure of the effect is the percentage of patients who were transfused. |
From discharge to 8 weeks postpartum
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The mean fatigue score measured by the Multidimensional Fatigue Inventory score-20 (MFI-20)
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire ( overall and in each of its 5 dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue). |
8 weeks postpartum, 6 months postpartum
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The proportion of women with high fatigue score (MIF-20 score>15)
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The mean relative change in MFI-20 scores
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The mean score for mother and child bonding measured by the Mother to Infant Bonding Scale (MIBS)
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The proportion of women with MIBS≥2
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The proportion of breastfeeding women and mean duration for those who stopped
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Participants will answer self assessment questionnaires |
8 weeks postpartum, 6 months postpartum
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The mean relative change in MIBS score
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The mean score of quality of life measured by EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels)
Periodo de tiempo: 8 weeks postpartum, 6 months postpartum
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EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels) overall and for each of the 5 dimensions |
8 weeks postpartum, 6 months postpartum
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The number of women in each group who also received the other group treatment within 8 weeks postpartum
Periodo de tiempo: Up to 8 weeks
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Women who needed IV iron in the oral iron group because of poorly tolerated anaemia, and women who took oral iron after hospital discharge in the IV iron group |
Up to 8 weeks
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Assessement of adverse events
Periodo de tiempo: From first drug administration to 8 weeks
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Incidence, nature, and severity of adverse events and serious adverse events |
From first drug administration to 8 weeks
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Compliance to treatment for participants in the oral iron arm
Periodo de tiempo: 8 weeks
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Good compliance defined by the overall drug intake >80% of the prescribed oral iron treatment |
8 weeks
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Total costs of healthcare resources for medicoeconomic cost-consequence analysis
Periodo de tiempo: Up to 6 months postpartum
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Use of resources and consequences for women are collected prospectively from the time of randomization up to 6 months by a a self-assessment questionnaire at 8 weeks and 6 months |
Up to 6 months postpartum
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marie-Pierre BONNET, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Director de estudio: Catherine DENEUX-THARAUX, MD, PhD, Assistance Publique - Hôpitaux de Paris
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APHP220806
- 2023-503283-17-00 (Ctis)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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