Peripartum Depression (PPD)PREVIDEPPNCT05632510
PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT
A study testing The Edinburgh Postnatal Depression Scale (EPDS) in people with Peripartum Depression (PPD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The risk of PPD for a woman giving birth ranges between 10 and 20% worldwide, with about a third of postpartum depression that begin during pregnancy. PPD has been associated to negative short-/long-term effects for the mother's health, the child's health and early interactions when left untreated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripartum Depression (PPD)
- What is being tested?
- The Edinburgh Postnatal Depression Scale (EPDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,471 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult women (aged > 18 years)
- Between 10 and 24 weeks pregnancy
- Fluent in written and spoken French (can understand a self-administered questionnaire);
- Affiliated to a social security scheme
- Informed consent obtained
Who cannot join
- Reported diagnosis of schizophrenia or physical and intellectual state incompatible with a clinical evaluation
- Persons unable to give their consent
- Unable adults (maintenance of justice, tutelage, legal guardianship)
- Person deprived of her liberty
- Patient on AME (state medical aid)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT: A CLUSTER-RANDOMIZED CONTROLLED TRIAL
The risk of PPD for a woman giving birth ranges between 10 and 20% worldwide, with about a third of postpartum depression that begin during pregnancy. PPD has been associated to negative short-/long-term effects for the mother's health, the child's health and early interactions when left untreated.
PPD is underdiagnosed, less than half of patients being diagnosed partly because of atypical symptoms, reluctance of patients to seek help, and because of the lack of systematic screening for this condition. Other specific biological changes could also be involved. Reduction in plasma oxytocin levels have been shown to be associated with the risk of PPD and heritability studies have identified a genetic contribution.
Read more
The Edinburgh Postnatal Depression Scale (EPDS) is a self-administered questionnaire of 10 items, is recommended by the NICE guideline and French National Authority for Health for screening peripartum women, validated in French and well accepted.
In France, the first contact with midwives or obstetricians during pregnancy usually occurs around the 4th month of pregnancy. French National Authority for Health recommends evaluation of risk factors for depression during this first consultation. However, this interview is rarely done probably because assessment of depression could be considered as difficult and time consuming. However, a meta-analysis shows that screening depression in the general population significantly reduces the risk for persistent depression (relative risk 0.87 [95%CI 0.79 to 0.95]), as compared to usual care.
Our hypothesis is that early identification of vulnerability/depression in pregnant women would enable clinical team to offer adequate psychological and psychosocial care during pregnancy, thus reducing PPD in these women.
The investigators propose to assess the impact of a systematic screening of depression using EPDS during an early consultation in comparison with usual practices, on the risk of depression during peripartum period (PPD).
Read the detailed description
Follow-up of pregnancy by medical staff will be performed as usual: referral to specific structures, according to the usual hospital care protocols, which do not fall within the scope of this protocol.
An independent psychologist will conduct blinded evaluation of perinatal depression using a semi-structured interview (DIGS) based on the DSM-5 criteria (i) between the first and fifth day postpartum and (ii) at 8 weeks post-partum to assess the primary endpoint. The interview will also allow assessment of management of specialized care during pregnancy and during postpartum at week 8 after childbirth (specialized consultation, psychotherapy, drug treatment: nature, frequency and doses for therapeutics).
The choice of a cluster randomization over individual randomization is justified by the risk of contamination bias in the depression screening. The choice of a clinician randomization over center randomization is justified by the high heterogeneity of patient's characteristics between centres.
- Conditions
- Peripartum Depression (PPD)
- Being tested
- The Edinburgh Postnatal Depression Scale (EPDS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Edinburgh Postnatal Depression Scale (EPDS)Diagnostic test
The Edinburgh Postnatal Depression Scale (EPDS) is a self-administered questionnaire of 10 items, is recommended by the NICE guideline and French National Authority for Health for screening peripartum women, validated in French and well accepted.
| Study group | Role | What they receive |
|---|---|---|
| EPDS Group | Other | Not described Receives: Diagnostic Test: The Edinburgh Postnatal Depression Scale (EPDS) |
| Courent practice Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perinatal major depressive episode during the period starting at 8 weeks before childbirth and ending 8 weeks postpartum.
To show the superiority of the implementation of the Edinburgh Postnatal Depression Scale (EPDS) as a depression screening tool during early pregnancy consultation, compared with usual depression screening to reduce the risk of peripartum depression.
The primary endpoint is the diagnosis of a depressive episode according to DSM-5 criteria during the period from 8 weeks before childbirth to 8 weeks postpartum.
Measured: 8 weeks before childbirth and 8 weeks postpartum
Secondary outcomes (4)
Antenatal (from 8 weeks before delivery to delivery) major depressive episode as defined by the DSM-5 criteria
assessed between the first and fifth days after birth.by a face-to-face interview conducted by a psychologist, using the DIGS
Measured: 8 weeks before childbirth and 8 weeks postpartum
Prevalence of a postpartum (from delivery to 8 weeks postpartum) major depressive episode as defined by the DSM-5 criteria
assessed at 8 weeks postpartum by a phone interview, conducted by a psychologist, using the DIGS
Measured: childbirth and 8 weeks postpartum
Specific care received by women from childbirth to 8 weeks after delivery
It will be assessed at the maternity department, by a face-to-face interview conducted by a psychologist.
Measured: childbirth and 8 weeks postpartum
Specific care received by women from childbirth to 8 weeks after delivery
(specialized consultation, psychotherapy, drug treatment, hospitalization in psychiatry, etc : nature, frequency, doses if therapeutics). It will be assessed by a phone interview, conducted by a psychologist.
Measured: childbirth and 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start21 Oct 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripartum 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 4,471 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline DUBERTRET, Principal investigator, Assistance Publique - Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632510
- Sponsor's protocol ID
- APHP200025
- Other IDs
- 2020-A03097-32
- Acronym
- PREVIDEPP
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT: A CLUSTER-RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05632510
- Acronym / sponsor ID
- PREVIDEPP / APHP200025
- Conditions
- Peripartum Depression (PPD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,471 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 30 Nov 2022 (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 risk of PPD for a woman giving birth ranges between 10 and 20% worldwide, with about a third of postpartum depression that begin during pregnancy. PPD has been associated to negative short-/long-term effects for the mother's health, the child's health and early interactions when left untreated.
PPD is underdiagnosed, less than half of patients being diagnosed partly because of atypical symptoms, reluctance of patients to seek help, and because of the lack of systematic screening for this condition. Other specific biological changes could also be involved. Reduction in plasma oxytocin levels have been shown to be associated with the risk of PPD and heritability studies have identified a genetic contribution.
The Edinburgh Postnatal Depression Scale (EPDS) is a self-administered questionnaire of 10 items, is recommended by the NICE guideline and French National Authority for Health for screening peripartum women, validated in French and well accepted.
In France, the first contact with midwives or obstetricians during pregnancy usually occurs around the 4th month of pregnancy. French National Authority for Health recommends evaluation of risk factors for depression during this first consultation. However, this interview is rarely done probably because assessment of depression could be considered as difficult and time consuming. However, a meta-analysis shows that screening depression in the general population significantly reduces the risk for persistent depression (relative risk 0.87 [95%CI 0.79 to 0.95]), as compared to usual care.
Our hypothesis is that early identification of vulnerability/depression in pregnant women would enable clinical team to offer adequate psychological and psychosocial care during pregnancy, thus reducing PPD in these women.
The investigators propose to assess the impact of a systematic screening of depression using EPDS during an early consultation in comparison with usual practices, on the risk of depression during peripartum period (PPD).
Detailed description
Follow-up of pregnancy by medical staff will be performed as usual: referral to specific structures, according to the usual hospital care protocols, which do not fall within the scope of this protocol.
An independent psychologist will conduct blinded evaluation of perinatal depression using a semi-structured interview (DIGS) based on the DSM-5 criteria (i) between the first and fifth day postpartum and (ii) at 8 weeks post-partum to assess the primary endpoint. The interview will also allow assessment of management of specialized care during pregnancy and during postpartum at week 8 after childbirth (specialized consultation, psychotherapy, drug treatment: nature, frequency and doses for therapeutics).
The choice of a cluster randomization over individual randomization is justified by the risk of contamination bias in the depression screening. The choice of a clinician randomization over center randomization is justified by the high heterogeneity of patient's characteristics between centres.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPDS Group | Other | Diagnostic Test: The Edinburgh Postnatal Depression Scale (EPDS) |
| Courent practice Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult women (aged > 18 years)
- Between 10 and 24 weeks pregnancy
- Fluent in written and spoken French (can understand a self-administered questionnaire);
- Affiliated to a social security scheme
- Informed consent obtained
Key exclusion criteria (5 listed)
- Reported diagnosis of schizophrenia or physical and intellectual state incompatible with a clinical evaluation
- Persons unable to give their consent
- Unable adults (maintenance of justice, tutelage, legal guardianship)
- Person deprived of her liberty
- Patient on AME (state medical aid)
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 |
|---|---|---|
| The Edinburgh Postnatal Depression Scale (EPDS)The Edinburgh Postnatal Depression Scale (EPDS) is a self-administered questionnaire of 10 items, is recommended by the NICE guideline and French National Authority for Health for screening peripartum women, validated in French and well accepted. | Diagnostic test | EPDS Group |
Primary outcome
The perinatal major depressive episode during the period starting at 8 weeks before childbirth and ending 8 weeks postpartum.
Time frame: 8 weeks before childbirth and 8 weeks postpartum
To show the superiority of the implementation of the Edinburgh Postnatal Depression Scale (EPDS) as a depression screening tool during early pregnancy consultation, compared with usual depression screening to reduce the risk of peripartum depression. The primary endpoint is the diagnosis of a depressive episode according to DSM-5 criteria during the period from 8 weeks before childbirth to 8 weeks postpartum.
4 secondary outcomes
Antenatal (from 8 weeks before delivery to delivery) major depressive episode as defined by the DSM-5 criteria
Time frame: 8 weeks before childbirth and 8 weeks postpartum
Prevalence of a postpartum (from delivery to 8 weeks postpartum) major depressive episode as defined by the DSM-5 criteria
Time frame: childbirth and 8 weeks postpartum
Specific care received by women from childbirth to 8 weeks after delivery
Time frame: childbirth and 8 weeks postpartum
Specific care received by women from childbirth to 8 weeks after delivery
Time frame: childbirth and 8 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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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. This study is not recruiting at the moment.
Caroline DUBERTRET principal investigator
Assistance Publique - Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Edinburgh Postnatal Depression Scale (EPDS) in people with Peripartum 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perinatal major depressive episode during the period starting at 8 weeks before childbirth and ending 8 weeks postpartum. (time frame: 8 weeks before childbirth and 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 30 Nov 2022.