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CompletedNCT04437342Updated Jan 6, 2021

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

An observational study in Postpartum Depression, Psychological Stress and Maternal Distress, sponsored by General and Maternity Hospital of Athens Elena Venizelou. Completed at 6 sites in Greece. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-06.

Sponsored by General and Maternity Hospital of Athens Elena Venizelou · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
330
Ages
18 Years and older
Sex
Female
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Study 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

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Conditions studied

  • Postpartum Depression
  • Psychological Stress
  • Maternal Distress

Keywords

  • postpartum depression
  • Covid-19 pandemic
  • anaesthesia
03

In context

Depression, Postpartum

536 studies on the registry are indexed under Depression, Postpartum; 126 are open to participants now.

This study's enrollment of 330 is above the median of 200 across 91 observational studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

General and Maternity Hospital of Athens Elena Venizelou is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pregnant women admitted to the hospital for vaginal delivery or caesarean section

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not eligible in writing and reading in Greek
  • Drug abuse
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
330 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Other: GAD-7 (General Anxiety Disorder) scale · Other: 38 questions questionnaire · Other: EPDS (Edinburgh Postnatal Depression Scale)

Interventions

  • OtherPHQ-9 (Patient Health Questionnaire) Depression Scale

    9 question questionnaire for assessment of depression

  • OtherGAD-7 (General Anxiety Disorder) scale

    7 question questionnaire for assessment of General Anxiety Disorder

  • Other38 questions questionnaire

    38 questions questionnaire

  • OtherEPDS (Edinburgh Postnatal Depression Scale)

    10 questions scale for detection of postpartum depression

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What researchers measure

Primary outcomes

  1. Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)

    Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)

    Time frame: 40 days postpartum

Secondary outcomes

  1. Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)

    Association 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

  2. Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain

    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)

    Time frame: 2 minutes prior to discharge from the Postanaesthesia care unit

  3. Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain

    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)

    Time frame: 2 minutes after admission to the Postanaesthesia care unit

07

Study locations

6 sites
  • "Elena Venizelou" General and Maternity Hospital of Athens
    Athens, Attica 11521, Greece
  • 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
    Larissa, Greece
08

References and documents

Individual participant data

Plan to share: Yes — Research data, study protocol and statistical analysis plan will be available to the scientific community after publication. The corresponding author is responsible for reviewing these requests.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: After publication of the article for indefinite time

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04437342
Lead sponsor
General and Maternity Hospital of Athens Elena Venizelou
Collaborators
National and Kapodistrian University of Athens, Alexandra Hospital, Athens, Greece, University of Ioannina, Larissa University Hospital
Responsible party
GEORGIA MICHA (Anaesthesiologist, MD, MSc, PhD, General and Maternity Hospital of Athens Elena Venizelou) — Principal investigator
First posted
Jun 18, 2020
Start date
Jun 30, 2020
Primary completion
Aug 30, 2020
Completion
Oct 27, 2020
Last update
Jan 6, 2021

Study contacts

Georgia Micha, PhD
principal investigator · Elena Venizelou General and Maternity Hospital of Athens, Greece

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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