Phase 4 Depression and Anxiety Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 or older
- People who have had a caesarean delivery (planned or emergency)
- People who gave birth at 32 weeks of pregnancy or later
- People whose haemoglobin (a measure of red blood cells) was measured within 72 hours after birth and fell within a specific moderate range — not too low, not normal (confirm with trial site for exact values)
- People whose iron stores (measured by ferritin level or transferrin saturation — two types of iron blood tests) are below a certain threshold, tested after the haemoglobin measurement
- People who scored below 11 on a postnatal mood questionnaire (called the EPDS) shortly after birth, and answered "never" to question 10 of that questionnaire
- People who have signed a consent form agreeing to take part
- People staying in the postnatal maternity ward
- People covered by French national social security, including AME (a form of French health coverage)
Who may not be able to join:
- People whose baby was stillborn or died shortly after birth
- People whose recorded body weight (measured late in pregnancy or after birth) was below 35kg or above 100kg
- People with Biermer disease (a condition affecting vitamin B12 absorption)
- People with haemochromatosis (a condition causing the body to store too much iron)
- People with homozygous sickle cell disease or thalassaemia (inherited blood disorders)
- People who were taking iron supplements regularly before pregnancy (not as part of pregnancy care)
- People with a known allergy or sensitivity to the iron treatments being studied (whether given by injection or by mouth)
- People for whom the iron treatments being studied (injectable or oral iron) are medically unsuitable
- People with severe asthma requiring daily ongoing medication
- People with a known serious kidney or liver condition
- People with an active infection at the time of joining
- People with a diagnosis of schizophrenia, or whose physical or intellectual condition would make it difficult to reliably complete self-assessment questionnaires
- People currently receiving medication or electroconvulsive therapy (ECT) for depression or bipolar disorder
- People already participating in another clinical trial that could affect haemoglobin levels at 2 months after birth, affect EPDS mood scores at 2 or 6 months after birth, or that involves a treatment with a risk of serious allergic reaction given during the postnatal hospital stay
- People who do not have a sufficient understanding of the French language
- People under legal guardianship or a formal protection order (curatorship or tutorship)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Marie-Pierre BONNET, MD, PhD, Assistance Publique - Hôpitaux de Paris
Phone: (+) 33 1 71 73 89 56
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.