PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT (PREVIDEPP)

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.

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Peripartum Depression (PPD)
• Intervention / Treatment: Diagnostic test: The Edinburgh Postnatal Depression Scale (EPDS)

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 Type: Interventional
• Enrollment (Anticipated): 4471
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Colombes, France
    • Louis Mourier Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EPDS Group	Diagnostic test: 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.
No Intervention: Courent practice Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks before childbirth and 8 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	childbirth and 8 weeks postpartum

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Caroline DUBERTRET, Assistance Publique - Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 30, 2025

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: APHP200025; 2020-A03097-32 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No