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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
2,860
Single dose of Ferric carboxymaltose 1000 mg (20mL) IV infusion (20ml vial of 1000mg iron or two 10ml vials of 500mg)
100 mg once a day (2 pills of TIMOFÉROL® 50mg)
CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale
Paris, France
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
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.
Time frame: 8 weeks postpartum
The mean Haemoglobin (Hb) level
All participants will have à haemoglobin measurment at 8 weeks
Time frame: 8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level
Haemoglobin measurment at 8 weeks
Time frame: At Inclusion and at 8 weeks postpartum
The proportion of women with Haemoglobin level < 12.0 g/dL
Haemoglobin measurment at 8 weeks
Time frame: 8 weeks postpartum
The mean ferritinemia level
Ferritinemia dosage at 8 weeks
Time frame: At Inclusion and at 8 weeks postpartum
The mean change in ferritinemia level
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Ferritinemia dosage at 8 weeks
Time frame: At Inclusion and at 8 weeks postpartum
The proportion of women with ferritinemia < 20 ng/mL
Ferritinemia dosage at 8 weeks
Time frame: 8 weeks postpartum
Mean EPDS score
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportions of participants with moderate depressive symptoms level defined by an EPDS ≥ 11 and <13
Edinburg Postpartum Depression Scale (EPDS) will be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportions of participants with high depressive symptoms level defined by an EPDS ≥13
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean change in EPDS score
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The need for red blood cell transfusion
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.
Time frame: From discharge to 8 weeks postpartum
The mean fatigue score measured by the Multidimensional Fatigue Inventory score-20 (MFI-20)
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).
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of women with high fatigue score (MIF-20 score>15)
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean relative change in MFI-20 scores
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean score for mother and child bonding measured by the Mother to Infant Bonding Scale (MIBS)
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of women with MIBS≥2
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of breastfeeding women and mean duration for those who stopped
Participants will answer self assessment questionnaires
Time frame: 8 weeks postpartum, 6 months postpartum
The mean relative change in MIBS score
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Time frame: 8 weeks postpartum, 6 months postpartum
The mean score of quality of life measured by EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels)
EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels) overall and for each of the 5 dimensions
Time frame: 8 weeks postpartum, 6 months postpartum
The number of women in each group who also received the other group treatment within 8 weeks postpartum
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
Time frame: Up to 8 weeks
Assessement of adverse events
Incidence, nature, and severity of adverse events and serious adverse events
Time frame: From first drug administration to 8 weeks
Compliance to treatment for participants in the oral iron arm
Good compliance defined by the overall drug intake \>80% of the prescribed oral iron treatment
Time frame: 8 weeks
Total costs of healthcare resources for medicoeconomic cost-consequence analysis
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
Time frame: Up to 6 months postpartum