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NCT04432948 Clinical Trial

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

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04432948
Other study ID # Maternal Covid 19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2020
Est. completion date December 2020

Study information
Verified date June 2020
Source General and Maternity Hospital of Athens Elena Venizelou
Contact Georgia Micha, Dr
Phone +306974828254
Email mgeo3@yahoo.gr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- psychiatric disorders

- drug abuse

- not eligible to read and write in Greek

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• PHQ-9 Depression Scale
It involves a 9-question scale that detects depression
• GAD-7 General anxiety disorder scale
It involves a 7-question scale that detects general anxiety disorder
• 38-questions questionnaire
It involves a 38 question questionnaire that aims to detect any association between the Covid-19 pandemic, the psychological impllications and anaesthetic practice

Locations
Country Name City State
Greece "Elena Venizelou" General and Maternity Hospital of Athens Athens Attica

Sponsors (1)
Lead Sponsor Collaborator
General and Maternity Hospital of Athens Elena Venizelou

Country where clinical trial is conducted

Greece, 

References & 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 May 6. doi: 10.1111/aogs.13894. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice Association between Covid-19 pandemic and anaesthetic practice assessed by a 38 questions questionnaire Pre-labour assessment
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