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

NCT04437342 | Completed

• 1 other identifier: Covid-19 Postpartum depression
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 6

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

Conditions

Postpartum Depression; Psychological Stress; Maternal Distress

Keywords

postpartum depression; Covid-19 pandemic; anaesthesia

Outcome Measures

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)

  40 days postpartum

Secondary Outcomes (3)

• Correlation 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

  2 minutes prior to discharge from the Postanaesthesia care unit

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

  2 minutes after admission to the Postanaesthesia care unit

Study Arms (1)

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

PHQ-9 (Patient Health Questionnaire) Depression Scale OTHER

9 question questionnaire for assessment of depression

Maternal Group

GAD-7 (General Anxiety Disorder) scale OTHER

7 question questionnaire for assessment of General Anxiety Disorder

Maternal Group

38 questions questionnaire OTHER

38 questions questionnaire

Maternal Group

EPDS (Edinburgh Postnatal Depression Scale) OTHER

10 questions scale for detection of postpartum depression

Maternal Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Maternity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General and Maternity Hospital of Athens Elena Venizelou: lead
• National and Kapodistrian University of Athens: collaborator
• Alexandra Hospital, Athens, Greece: collaborator
• University of Ioannina: collaborator
• Larissa University Hospital: collaborator

Study Sites (6)

"Elena Venizelou" General and Maternity Hospital of Athens

Athens, Attica, 11521, Greece

Location

Aretaieio University Hospital

Athens, Attica, Greece

Location

Alexandra Genaral Hospital Athens

Athens, Greece

Location

University of Ioannina Health Science

Ioannina, Greece

Location

University of Ioannina, Medical School

Ioannina, Greece

Location

University of Thessaly Medical School

Larissa, Greece

Location

MeSH Terms

Conditions

Depression, Postpartum; Stress, Psychological; COVID-19

Interventions

Patient Health Questionnaire; Weights and Measures; Psychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Neuropsychological Tests

Study Officials

• Georgia Micha, PhD

  Elena Venizelou General and Maternity Hospital of Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiologist, MD, MSc, PhD

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: June 30, 2020
• Primary Completion: August 30, 2020
• Study Completion: October 27, 2020
• Last Updated: January 6, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication of the article for indefinite time

Locations

GR (6)