Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
Condition(s) studied
Investigational drug(s) / intervention(s)
Ferric carboxymaltose IV: Single dose of Ferric carboxymaltose 1000 mg (20mL) IV infusion (20ml vial of 1000mg iron or two 10ml vials of 500mg)
TIMOFÉROL®: 100 mg once a day (2 pills of TIMOFÉROL® 50mg)
Study summary
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
Primary outcome measure(s)
- Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11 — 8 weeks postpartum
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale | Paris | France | Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06833788 on ClinicalTrials.gov ↗ ← All trials in France