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

June 14, 2020 updated by: GEORGIA MICHA, General and Maternity Hospital of Athens Elena Venizelou
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georgia Micha, Dr
  • Phone Number: +306974828254
  • Email: mgeo3@yahoo.gr

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11521
        • Recruiting
        • "Elena Venizelou" General and Maternity Hospital of Athens
        • Contact:
          • Georgia Micha, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Maternal Group
Pregnant women administered into a maternity public hospital in labour (vaginal delivery, caesarean section)
Other: PHQ-9 Depression Scale
It involves a 9-question scale that detects depression
Other: GAD-7 General anxiety disorder scale
It involves a 7-question scale that detects general anxiety disorder
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Covid-19 pandemic and maternal psychological distress
Time Frame: Pre-labour assessment
Association between Covid-19 pandemic and maternal psychological distress assessed by 2 scales and one questionnaire
Pre-labour assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice
Time Frame: Pre-labour assessment
Association between Covid-19 pandemic and anaesthetic practice assessed by a 38 questions questionnaire
Pre-labour assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General and Maternity Hospital of Athens Elena Venizelou

Investigators

  • Principal Investigator: Georgia Micha, Dr, Elena Venizelou General and Maternity Hospital of Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 14, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 14, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Maternal Covid 19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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