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Clinical Trials/NCT04377412
NCT04377412
Unknown
N/A

Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

Żelazna Medical Centre, LLC17 sites in 15 countries8,500 target enrollmentMay 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Żelazna Medical Centre, LLC
Enrollment
8500
Locations
17
Primary Endpoint
Anxiety
Last Updated
5 years ago

Overview

Brief Summary

The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
October 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Żelazna Medical Centre, LLC
Responsible Party
Principal Investigator
Principal Investigator

Anna Kajdy

Md, PhD

Centre of Postgraduate Medical Education

Eligibility Criteria

Inclusion Criteria

  • declaration of being pregnant
  • being able to complete the survey in the available languages
  • answer the screening questions
  • provide informed consent for participation

Exclusion Criteria

  • not providing online informed consent for participation
  • if the participant does not click on the submit button at the end of the survey
  • not answer all the GAD-7 and PHQ-9 scale questions

Outcomes

Primary Outcomes

Anxiety

Time Frame: 4 months

Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; \>15 severe. Minimum 0, maximum 21 points

Depression

Time Frame: 4 months

Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; \>20 severe. Minimum 0 maximum 27 points

Study Sites (17)

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