Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.

NCT04432948 | Unknown

• 1 other identifier: Maternal Covid 19
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the maternal psychological implication of the novel coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice.

Conditions

Covid-19; Maternal Psychological Distress; Anesthesia

Keywords

Covid-19; Psychological Distress; Maternal; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Association between Covid-19 pandemic and maternal psychological distress

  Association between Covid-19 pandemic and maternal psychological distress assessed by 2 scales and one questionnaire

  Pre-labour assessment

Secondary Outcomes (1)

• Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice

  Pre-labour assessment

Study Arms (1)

Maternal Group

Pregnant women administered into a maternity public hospital in labour (vaginal delivery, caesarean section)

Other: PHQ-9 Depression Scale; Other: GAD-7 General anxiety disorder scale; Other: 38-questions questionnaire

Interventions

PHQ-9 Depression Scale OTHER

It involves a 9-question scale that detects depression

Maternal Group

GAD-7 General anxiety disorder scale OTHER

It involves a 7-question scale that detects general anxiety disorder

Maternal Group

38-questions questionnaire OTHER

It involves a 38 question questionnaire that aims to detect any association between the Covid-19 pandemic, the psychological impllications and anaesthetic practice

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

All women in labour that present into the maternity hospital from June-August 2020, during the Covid-19 pandemic

You may qualify if:

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

You may not qualify if:

• psychiatric disorders
• drug abuse
• not eligible to read and write in Greek

Sponsors & Collaborators

• General and Maternity Hospital of Athens Elena Venizelou: lead

Study Sites (1)

"Elena Venizelou" General and Maternity Hospital of Athens

Athens, Attica, 11521, Greece

RECRUITING

Related Publications (1)

• Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.

  PMID: 32374420 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

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

Study Officials

• Georgia Micha, Dr

  Elena Venizelou General and Maternity Hospital of Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia Micha, Dr

CONTACT

+306974828254; mgeo3@yahoo.gr

Study Design

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

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 16, 2020
• Study Start: May 15, 2020
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

GR (1)