Postpartum Depression (PPD)Phase 4IRON-DEPNCT06833788
Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
A Phase 4 study testing Ferric carboxymaltose IV and TIMOFÉROL® in people with Postpartum Depression (PPD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- Ferric carboxymaltose IV and TIMOFÉROL®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,860 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2025to 30 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Homozygous sickle cell disease or thalassemia
- Chronic iron supplementation (outside pregnancy)
Show all 19Show fewer
- Known hypersensitivity or allergy to the studied drugs (IV or oral iron)
- Contra-indication to the studied drugs (IV or oral iron)
- Severe asthma (with daily background treatment)
- Any known severe renal or liver disorder
- Active acute infection
- Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation
- Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders
- 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.
- Poor understanding of the French language
- Legal protection (curatorship or tutorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale
Paris, 75012
About this study
Official title: Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression: a Multicentric Randomized Open-labelled Controlled 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.
Read the detailed description
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.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- Ferric carboxymaltose IV, TIMOFÉROL®
- Keywords
- Postpartum depression (PPD), Postpartum anaemia, Caesarean, Intravenous (IV) iron therapy, Oral iron therapy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltose IVDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron | Experimental | Women in the experimental arm will receive an IV iron infusion within 5 days after delivery |
| Oral iron | Active comparator | Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks postpartum
Secondary outcomes (23)
The mean Haemoglobin (Hb) level
All participants will have à haemoglobin measurment at 8 weeks
Measured: 8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level
Haemoglobin measurment at 8 weeks
Measured: At Inclusion and at 8 weeks postpartum
The proportion of women with Haemoglobin level < 12.0 g/dL
Haemoglobin measurment at 8 weeks
Measured: 8 weeks postpartum
The mean ferritinemia level
Ferritinemia dosage at 8 weeks
Measured: At Inclusion and at 8 weeks postpartum
The mean change in ferritinemia level
Ferritinemia dosage at 8 weeks
Measured: At Inclusion and at 8 weeks postpartum
The proportion of women with ferritinemia < 20 ng/mL
Ferritinemia dosage at 8 weeks
Measured: 8 weeks postpartum
Mean EPDS score
Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 8 weeks postpartum, 6 months postpartum
The mean relative change in MFI-20 scores
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
Measured: 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
Measured: 8 weeks postpartum, 6 months postpartum
The proportion of women with MIBS≥2
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Measured: 8 weeks postpartum, 6 months postpartum
The proportion of breastfeeding women and mean duration for those who stopped
Participants will answer self assessment questionnaires
Measured: 8 weeks postpartum, 6 months postpartum
The mean relative change in MIBS score
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
Measured: 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
Measured: 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
Measured: Up to 8 weeks
Assessement of adverse events
Incidence, nature, and severity of adverse events and serious adverse events
Measured: 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
Measured: 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
Measured: Up to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start22 Oct 2025
- Primary completion22 Jun 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre BONNET, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisCatherine DENEUX-THARAUX, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833788
- Sponsor's protocol ID
- APHP220806
- Other IDs
- 2023-503283-17-00, 2023
- Acronym
- IRON-DEP
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression: a Multicentric Randomized Open-labelled Controlled Trial
- ClinicalTrials.gov ID
- NCT06833788
- Acronym / sponsor ID
- IRON-DEP / APHP220806
- Conditions
- Postpartum Depression (PPD)
- Keywords
- Postpartum depression (PPD), Postpartum anaemia, Caesarean, Intravenous (IV) iron therapy, Oral iron therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,860 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 22 Jun 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron | Experimental | –Women in the experimental arm will receive an IV iron infusion within 5 days after delivery |
| Oral iron | Active comparator | –Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (19 listed)
- 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
- Homozygous sickle cell disease or thalassemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltose IVSingle dose of Ferric carboxymaltose 1000 mg (20mL) IV infusion (20ml vial of 1000mg iron or two 10ml vials of 500mg) | Drug | – |
| TIMOFÉROL®100 mg once a day (2 pills of TIMOFÉROL® 50mg) | Drug | – |
Primary outcome
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
Time frame: 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.
23 secondary outcomes
The mean Haemoglobin (Hb) level
Time frame: 8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level
Time frame: At Inclusion and at 8 weeks postpartum
The proportion of women with Haemoglobin level < 12.0 g/dL
Time frame: 8 weeks postpartum
The mean ferritinemia level
Time frame: At Inclusion and at 8 weeks postpartum
The mean change in ferritinemia level
Time frame: At Inclusion and at 8 weeks postpartum
The proportion of women with ferritinemia < 20 ng/mL
Time frame: 8 weeks postpartum
Mean EPDS score
Time frame: 8 weeks postpartum, 6 months postpartum
The proportions of participants with moderate depressive symptoms level defined by an EPDS ≥ 11 and <13
Time frame: 8 weeks postpartum, 6 months postpartum
The proportions of participants with high depressive symptoms level defined by an EPDS ≥13
Time frame: 8 weeks postpartum, 6 months postpartum
The mean change in EPDS score
Time frame: 8 weeks postpartum, 6 months postpartum
The need for red blood cell transfusion
Time frame: From discharge to 8 weeks postpartum
The mean fatigue score measured by the Multidimensional Fatigue Inventory score-20 (MFI-20)
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of women with high fatigue score (MIF-20 score>15)
Time frame: 8 weeks postpartum, 6 months postpartum
The mean relative change in MFI-20 scores
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)
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of women with MIBS≥2
Time frame: 8 weeks postpartum, 6 months postpartum
The proportion of breastfeeding women and mean duration for those who stopped
Time frame: 8 weeks postpartum, 6 months postpartum
The mean relative change in MIBS score
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)
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
Time frame: Up to 8 weeks
Assessement of adverse events
Time frame: From first drug administration to 8 weeks
Compliance to treatment for participants in the oral iron arm
Time frame: 8 weeks
Total costs of healthcare resources for medicoeconomic cost-consequence analysis
Time frame: Up to 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Pierre BONNET, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Catherine DENEUX-THARAUX, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric carboxymaltose IV and TIMOFÉROL® in people with Postpartum Depression (PPD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Pierre BONNET, MD, PhD ((+) 33 1 71 73 89 56, marie-pierre.bonnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11 (time frame: 8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.