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

Study Overview

• Status: Completed
• Conditions: Postpartum Depression; Psychological Stress; Maternal Distress
• Intervention / Treatment: 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)

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Alexandra Genaral Hospital Athens
  • Ioannina, Greece
    • University of Ioannina Health Science
  • Ioannina, Greece
    • University of Ioannina, Medical School
  • Larisa, Greece
    • University of Thessaly Medical School
  • Attica
    • Athens, Attica, Greece, 11521
      • "Elena Venizelou" General and Maternity Hospital of Athens
    • Athens, Attica, Greece
      • Aretaieio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	40 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	10 minutes postpartum
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)	2 minutes prior to discharge from the Postanaesthesia care unit
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)	2 minutes after admission to the Postanaesthesia care unit

Collaborators and Investigators

• Sponsor: General and Maternity Hospital of Athens Elena Venizelou
• Collaborators: National and Kapodistrian University of Athens; University of Ioannina; Larissa University Hospital; Alexandra Hospital, Athens, Greece
• Investigators: Principal Investigator: Georgia Micha, PhD, Elena Venizelou General and Maternity Hospital of Athens, Greece

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2020
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): October 27, 2020

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: anaesthesia; postpartum depression; Covid-19 pandemic
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Mood Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; COVID-19; Stress, Psychological; Depression, Postpartum
• Other Study ID Numbers: Covid-19 Postpartum depression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After publication of the article for indefinite time
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No