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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437342
Recruitment Status : Completed
First Posted : June 18, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborators:
National and Kapodistrian University of Athens
Alexandra Hospital, Athens, Greece
University of Ioannina
Larissa University Hospital
Information provided by (Responsible Party):
GEORGIA MICHA, General and Maternity Hospital of Athens Elena Venizelou

Brief Summary:
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

Condition or disease Intervention/treatment
Postpartum Depression Psychological Stress Maternal Distress Other: PHQ-9 (Patient Health Questionnaire) Depression Scale Other: GAD-7 (General Anxiety Disorder) scale Other: 38 questions questionnaire Other: EPDS (Edinburgh Postnatal Depression Scale)

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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia
Actual Study Start Date : June 30, 2020
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : October 27, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: PHQ-9 (Patient Health Questionnaire) Depression Scale
9 question questionnaire for assessment of depression

Other: GAD-7 (General Anxiety Disorder) scale
7 question questionnaire for assessment of General Anxiety Disorder

Other: 38 questions questionnaire
38 questions questionnaire

Other: EPDS (Edinburgh Postnatal Depression Scale)
10 questions scale for detection of postpartum depression




Primary Outcome Measures :
  1. Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale) [ Time Frame: 40 days postpartum ]
    Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)


Secondary Outcome Measures :
  1. Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery) [ Time Frame: 10 minutes postpartum ]
    Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)

  2. Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain [ Time Frame: 2 minutes prior to discharge from the Postanaesthesia care unit ]
    Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)

  3. Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain [ Time Frame: 2 minutes after admission to the Postanaesthesia care unit ]
    Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Maternity
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women admitted to the hospital for vaginal delivery or caesarean section
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437342


Locations
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Greece
"Elena Venizelou" General and Maternity Hospital of Athens
Athens, Attica, Greece, 11521
Aretaieio University Hospital
Athens, Attica, Greece
Alexandra Genaral Hospital Athens
Athens, Greece
University of Ioannina Health Science
Ioannina, Greece
University of Ioannina, Medical School
Ioannina, Greece
University of Thessaly Medical School
Larisa, Greece
Sponsors and Collaborators
General and Maternity Hospital of Athens Elena Venizelou
National and Kapodistrian University of Athens
Alexandra Hospital, Athens, Greece
University of Ioannina
Larissa University Hospital
Investigators
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Principal Investigator: Georgia Micha, PhD Elena Venizelou General and Maternity Hospital of Athens, Greece
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Responsible Party: GEORGIA MICHA, Anaesthesiologist, MD, MSc, PhD, General and Maternity Hospital of Athens Elena Venizelou
ClinicalTrials.gov Identifier: NCT04437342    
Other Study ID Numbers: Covid-19 Postpartum depression
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GEORGIA MICHA, General and Maternity Hospital of Athens Elena Venizelou:
postpartum depression
Covid-19 pandemic
anaesthesia
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Stress, Psychological
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications