NCT05632510: PREVIDEPP

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

Status unknown NA Last updated 30 November 2022

What this trial tests

NA trial testing The Edinburgh Postnatal Depression Scale (EPDS) in Peripartum Depression (PPD) in 4,471 participants. Status unknown.

Timeline

21 October 2022

Primary endpoint
1 July 2025

30 July 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	4,471
Start date	21 October 2022
Primary completion	1 July 2025
Estimated completion	30 July 2025
Sites	1 location across France

Drugs / interventions tested

• The Edinburgh Postnatal Depression Scale (EPDS)

Conditions studied

• Peripartum Depression (PPD) — all drugs for Peripartum Depression (PPD) →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, female only, with Peripartum Depression (PPD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.