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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04377412




Registration number
NCT04377412
Ethics application status
Date submitted
2/05/2020
Date registered
6/05/2020
Date last updated
6/05/2020

Titles & IDs
Public title
Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic
Scientific title
Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey
Secondary ID [1] 0 0
Maternal axiety and COVID-19
Universal Trial Number (UTN)
Trial acronym
MindCOVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 0 0
Depression 0 0
Pregnancy Related 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Pandemic control measures

Albania -

Australia -

Czech Republic -

France -

Germany -

Hong Kong -

Israel -

Italy -

Lebanon -

Norway -

Poland -

Russia -

Spain -

Sweden -

Taiwan -

Ukraine -

United States -


Other interventions: Pandemic control measures
Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anxiety - Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points
Timepoint [1] 0 0
4 months
Primary outcome [2] 0 0
Depression - 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
Timepoint [2] 0 0
4 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
Albania
State/province [2] 0 0
Tirana
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Hong Kong
Country [7] 0 0
Israel
State/province [7] 0 0
Kafr Saba
Country [8] 0 0
Italy
State/province [8] 0 0
Brescia
Country [9] 0 0
Lebanon
State/province [9] 0 0
Beirut
Country [10] 0 0
Norway
State/province [10] 0 0
Tromsø
Country [11] 0 0
Poland
State/province [11] 0 0
Bydgoszcz
Country [12] 0 0
Poland
State/province [12] 0 0
Szczecin
Country [13] 0 0
Poland
State/province [13] 0 0
Warsaw
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
Sweden
State/province [15] 0 0
Stockholm
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Other
Name
Zelazna Medical Centre, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Medicine, Tirana
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Charles University, Czech Republic
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Hôpital Necker-Enfants Malades
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Charite University, Berlin, Germany
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Chinese University of Hong Kong
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Meir Medical Center
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Università degli Studi di Brescia
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
American University of Beirut Medical Center
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Karolinska Institutet
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Pomeranian Medical University Szczecin
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Nicolaus Copernicus University
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Centre of Postgraduate Medical Education
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Polish Academy of Sciences
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Taiji Clinic, Taipei
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Wayne State University
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
Chang Gung University
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
University of Tromso
Address [20] 0 0
Country [20] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04377412
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anna Kajdy, MD, PhD
Address 0 0
Centre of Postgraduate Medical Education
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anna Kajdy, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+48663769515
Fax 0 0
Email 0 0
akajdy@cmkp.edu.pl
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04377412