Health TrialsbyHealthPanel

Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression

ConditionPostpartum Depression (PPD)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Stillbirth or neonatal death

Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) < 35kg or > 100kg

Biermer disease

Hemochromatosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ferric carboxymaltose IV

    Drug

    Single dose of Ferric carboxymaltose 1000 mg (20mL) IV infusion (20ml vial of 1000mg iron or two 10ml vials of 500mg)

  • TIMOFÉROL®

    Drug

    100 mg once a day (2 pills of TIMOFÉROL® 50mg)

Treatment groups

2,860 Participants
are divided into 2 treatment groups
Group A: Intravenous ironExperimental treatment 0 interventions
Group B: Oral ironActive comparator 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

The mean Haemoglobin (Hb) level

All participants will have à haemoglobin measurment at 8 weeks

Time frame
8 weeks postpartum
2

Change in postpartum Haemoglobin (Hb) level

Haemoglobin measurment at 8 weeks

Time frame
At Inclusion and at 8 weeks postpartum
3

The proportion of women with Haemoglobin level < 12.0 g/dL

Haemoglobin measurment at 8 weeks

Time frame
8 weeks postpartum
4

The mean ferritinemia level

Ferritinemia dosage at 8 weeks

Time frame
At Inclusion and at 8 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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