Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia

NCT ID: NCT04437342

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-10-27

Brief Summary

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The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables

Detailed Description

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Conditions

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Postpartum Depression Psychological Stress Maternal Distress

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Maternal Group

Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression.

GAD-7 (General Anxiety Disorder) scale

Intervention Type OTHER

7 question questionnaire for assessment of General Anxiety Disorder

38 questions questionnaire

Intervention Type OTHER

38 questions questionnaire

EPDS (Edinburgh Postnatal Depression Scale)

Intervention Type OTHER

10 questions scale for detection of postpartum depression

PHQ-9 (Patient Health Questionnaire) Depression Scale

Intervention Type OTHER

9 question questionnaire for assessment of depression

Interventions

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GAD-7 (General Anxiety Disorder) scale

7 question questionnaire for assessment of General Anxiety Disorder

Intervention Type OTHER

38 questions questionnaire

38 questions questionnaire

Intervention Type OTHER

EPDS (Edinburgh Postnatal Depression Scale)

10 questions scale for detection of postpartum depression

Intervention Type OTHER

PHQ-9 (Patient Health Questionnaire) Depression Scale

9 question questionnaire for assessment of depression

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All pregnant women over the age of 18 that present for labour (vaginal delivery or caesarean section)

Exclusion Criteria

* Not eligible in writing and reading in Greek
* Drug abuse
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Alexandra Hospital, Athens, Greece

OTHER

Sponsor Role collaborator

University of Ioannina

OTHER

Sponsor Role collaborator

Larissa University Hospital

OTHER

Sponsor Role collaborator

General and Maternity Hospital of Athens Elena Venizelou

OTHER

Sponsor Role lead

Responsible Party

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GEORGIA MICHA

Anaesthesiologist, MD, MSc, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgia Micha, PhD

Role: PRINCIPAL_INVESTIGATOR

Elena Venizelou General and Maternity Hospital of Athens, Greece

Locations

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"Elena Venizelou" General and Maternity Hospital of Athens

Athens, Attica, Greece

Site Status

Aretaieio University Hospital

Athens, Attica, Greece

Site Status

Alexandra Genaral Hospital Athens

Athens, , Greece

Site Status

University of Ioannina Health Science

Ioannina, , Greece

Site Status

University of Ioannina, Medical School

Ioannina, , Greece

Site Status

University of Thessaly Medical School

Larissa, , Greece

Site Status

Countries

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Greece

Other Identifiers

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Covid-19 Postpartum depression

Identifier Type: -

Identifier Source: org_study_id

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