NCT04368208

Brief Summary

Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health. The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression. It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 29, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2020

Completed
Last Updated

January 26, 2021

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 28, 2020

Last Update Submit

January 25, 2021

Conditions

Keywords

childbirthcovid 19satisfaction

Outcome Measures

Primary Outcomes (1)

  • Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia

    proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum

    4-6 weeks postpartum

Secondary Outcomes (2)

  • Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia

    4-6 weeks postpartum

  • Describe the experience and the satisfaction about delivery during the covid 19 pandemia

    within the week after delivery

Interventions

The Edinburgh questionnaire is a self questionnaire validated for postnatal depression between 4 and 6 weeks postnatal

Also known as: Assessment of satisfaction about childbirth using the WOMBLSQ4 questionnaire within the week after delivery, Retrospective assessment of prenatal anxiety within the week after the delivery, Assessment of pelvic floor disorders using the PFDI questionnaire between 4 and 6 weeks after delivery, Assessment of self rated health for the woman and the child using the WHO question about self rated health between 4 and 6 weeks after delivery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who deliver of a single baby, at term and in cephalic presentation whatever is the modalities of delivery (instrumental, cesarean, spontaneous delivery) will be included after their delivery. Premature and non cephalic birth will be excluded because they are specific deliveries that may be assoictaed with a specific maternal anxietey. Women with psychiatric disorders are excluded since we investigated the occurrence of postnatal depression which is a psychiatric disorder. Women without any internet access are excluded because women will have to fill online questionnaires. Finally women will be informed, as well as their doctors, in case of postnatal depression with an advice of planning a medical consultation.

You may qualify if:

  • women older than 18 years
  • women who deliver of a singleton, term neonate in cephalic presentation

You may not qualify if:

  • women younger than 18 years
  • women who deliver of a baby in non cephalic presentation
  • women with pre term Birth
  • women without any internet access
  • women with psychiatric disorders
  • women who do not understand french language
  • women who refuse to be aware of the results of the postnatal depression screening and who refuse that her doctor be ware of the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bertrand GACHON

Poitiers, France

Location

MeSH Terms

Conditions

Depression, PostpartumCOVID-19Personal Satisfaction

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 DiseasesBehavior

Study Design

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

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 29, 2020

Study Start

April 29, 2020

Primary Completion

October 21, 2020

Study Completion

November 27, 2020

Last Updated

January 26, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations