NCT04516668

Brief Summary

Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

October 6, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

August 17, 2020

Last Update Submit

October 5, 2020

Conditions

Keywords

Post Partum DepressionTele-consultationCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Hospital anxiety and depression scale (HAD)

    To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation Score less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed case

    15 minutes

Secondary Outcomes (6)

  • Evaluation of Edinburgh Postpartum Depression Scale (EPDS)

    15 minutes

  • Evaluation of HAD score in fathers

    15 minutes

  • Evaluation of EPDS in fathers

    15 minutes

  • Study of the relationship between maternals and paternals symptoms

    15 minutes

  • Study of difficuties in child during the quarantine

    15 minutes

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who were treated by the psychiatry department at Bicêtre hospital for post-partum depression between 2013 and late 2019 and their partner

You may qualify if:

  • Women above 18 years old
  • Who have experienced a post-partum depression between 2013 and late of 2019
  • Who have benefit a psychiatry post-partum follow-up (hospitalizations in psychiatry post-partum unity and/or medical consultation) by Bicêtre psychiatry service
  • Who have a child less than 7 years old (preschool age)
  • Speaking and reading in french
  • And their partner (above 18 years old)
  • In the main analyze, only women with a indication of following psychiatric follow-up by tele-consultation (with a psychiatric follow-up at the begenning of the quarantine, who have not been follow-up by psychiatrist in hospitalization or in face to face consultation) will be analyzed

You may not qualify if:

  • People with chronic psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders:DSM-5 criteria)
  • People with mental handicap
  • People who are not able to give their consent
  • People subject to protection measure
  • People refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression, PostpartumCOVID-19

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

Study Officials

  • Florence Gressier, Dr

    Bicêtre Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Gressier, Dr

CONTACT

Emmanuelle Corruble, Pr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 18, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

October 6, 2020

Record last verified: 2020-07