PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT (PREVIDEPP)
Primary Purpose
Peripartum Depression (PPD)
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The Edinburgh Postnatal Depression Scale (EPDS)
Sponsored by
About this trial
This is an interventional prevention trial for Peripartum Depression (PPD)
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Sites / Locations
- Louis Mourier hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
EPDS Group
Courent practice Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
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.
Full Information
NCT ID
NCT05632510
First Posted
October 31, 2022
Last Updated
November 21, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05632510
Brief Title
PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT
Acronym
PREVIDEPP
Official Title
PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT: A CLUSTER-RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripartum Depression (PPD)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
4471 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EPDS Group
Arm Type
Other
Arm Title
Courent practice Group
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
The Edinburgh Postnatal Depression Scale (EPDS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The perinatal major depressive episode during the period starting at 8 weeks before childbirth and ending 8 weeks postpartum.
Description
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.
Time Frame
8 weeks before childbirth and 8 weeks postpartum
Secondary Outcome Measure Information:
Title
Antenatal (from 8 weeks before delivery to delivery) major depressive episode as defined by the DSM-5 criteria
Description
assessed between the first and fifth days after birth.by a face-to-face interview conducted by a psychologist, using the DIGS
Time Frame
8 weeks before childbirth and 8 weeks postpartum
Title
Prevalence of a postpartum (from delivery to 8 weeks postpartum) major depressive episode as defined by the DSM-5 criteria
Description
assessed at 8 weeks postpartum by a phone interview, conducted by a psychologist, using the DIGS
Time Frame
childbirth and 8 weeks postpartum
Title
Specific care received by women from childbirth to 8 weeks after delivery
Description
It will be assessed at the maternity department, by a face-to-face interview conducted by a psychologist.
Time Frame
childbirth and 8 weeks postpartum
Title
Specific care received by women from childbirth to 8 weeks after delivery
Description
(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.
Time Frame
childbirth and 8 weeks postpartum
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline DUBERTRET
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris (AP-HP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Mourier hospital
City
Colombes
Country
France
12. IPD Sharing Statement
Learn more about this trial
PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT
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