NCT04487171

Brief Summary

Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

July 24, 2020

Last Update Submit

March 21, 2023

Conditions

Keywords

Postpartum DepressionCovid19PrevalenceSocial Distance

Outcome Measures

Primary Outcomes (1)

  • Variation of prevalence of clinically-significant post-partum depressive symptoms

    Variation of prevalence of clinically-significant post-partum depressive symptoms

    up to 35 days after delivery

Interventions

The mothers were administrated three questionnaires, (i) the Edinburgh Postnatal Depression Scale (EPDS), (ii) the State-Trait Anxiety Inventory (STAI-YA), and (iii) the Mother-to-Infant Bonding Scale (MIBS) in two stages, on days 2-3 after delivery and during a phone call between days 25-35.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who deliver
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single baby delivery
  • alive new born child without admission in neonatal intensive care unit
  • French-speaking mother
  • mother older than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Depression, PostpartumCOVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Arthur FOULON, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 27, 2020

Study Start

July 21, 2020

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations