Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic

Depression Clinical Trial

— MindCOVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377412
• Other study ID #: Maternal axiety and COVID-19
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: May 2020
• Source: Zelazna Medical Centre, LLC
• Contact: Anna Kajdy, MD, PhD
• Phone: +48663769515
• Email: akajdy[@]cmkp.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8500
• Est. completion date: October 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Pregnancy Related

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Albania	University of Medicine Tirana	Tirana
Australia	Royal Prince Alfred Hospital	Sydney
Czechia	Charles University	Prague
France	Université de Paris	Paris
Germany	Charité - University Medicine Berlin	Berlin
Hong Kong	The Chinese University of Hong Kong	Hong Kong
Israel	Meir Medical Center	Kafr Saba
Italy	University of Brescia	Brescia
Lebanon	American University of Beirut	Beirut
Norway	The Arctic University of Norway	Tromsø
Poland	Nicolaus Copernicus University in Torun, Collegium Medicum in Bydgoszcz	Bydgoszcz
Poland	Pomeranian Medical University	Szczecin
Poland	Centre of Postgraduate Medical Education	Warsaw
Spain	11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"	Madrid
Sweden	Karolinska Institutet	Stockholm
Taiwan	Taiji Clinic	Taipei
United States	Wayne State University	Detroit	Michigan

Sponsors (21)

Lead Sponsor

Collaborator

Zelazna Medical Centre, LLC

American University of Beirut Medical Center, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, Centre of Postgraduate Medical Education, Chang Gung University, Charite University, Berlin, Germany, Charles University, Czech Republic, Chinese University of Hong Kong, Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal “iMaterna”, Madrid, Hôpital Necker-Enfants Malades, Karolinska Institutet, Meir Medical Center, Nicolaus Copernicus University, Polish Academy of Sciences, Pomeranian Medical University Szczecin, Royal Prince Alfred Hospital, Sydney, Australia, Taiji Clinic, Taipei, Università degli Studi di Brescia, University of Medicine, Tirana, University of Tromso, Wayne State University

Countries where clinical trial is conducted

United States,  Albania,  Australia,  Czechia,  France,  Germany,  Hong Kong,  Israel,  Italy,  Lebanon,  Norway,  Poland,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months
Primary	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	4 months