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Completed

NCT Number: NCT04437342

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

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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Key information

Conditions

Postpartum Depression Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Maternal Distress Mental Disorders Mood Disorders Nidovirales Infections Pneumonia Pneumonia, Viral Pregnancy Complications Psychological Stress Puerperal Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress, Psychological Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

"Elena Venizelou" General and Maternity Hospital of Athens, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHQ-9 (Patient Health Questionnaire) Depression Scale

Other

9 question questionnaire for assessment of depression

GAD-7 (General Anxiety Disorder) scale

Other

7 question questionnaire for assessment of General Anxiety Disorder

38 questions questionnaire

Other

38 questions questionnaire

EPDS (Edinburgh Postnatal Depression Scale)

Other

10 questions scale for detection of postpartum depression

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

General and Maternity Hospital of Athens Elena Venizelou

Other

Collaborators

  • Alexandra Hospital, Athens, Greece
  • Larissa University Hospital
  • National and Kapodistrian University of Athens
  • University of Ioannina

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2020
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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