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

• Conditions: Anxiety; Depression; Pregnancy Related

• Registration Number: NCT04377412
• Lead Sponsor: Żelazna Medical Centre, LLC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-01
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06
• Primary Completion: 2020-08-31
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 8500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety	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	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

Trial Locations

Locations (17)

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of Medicine Tirana; 🇦🇱 Tirana, Albania

Royal Prince Alfred Hospital; 🇦🇺 Sydney, Australia

Charles University; 🇨🇿 Prague, Czechia

Université de Paris; 🇫🇷 Paris, France

Charité - University Medicine Berlin; 🇩🇪 Berlin, Germany

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong

Meir Medical Center; 🇮🇱 Kafr Saba, Israel

University of Brescia; 🇮🇹 Brescia, Italy

American University of Beirut; 🇱🇧 Beirut, Lebanon

Scroll for more (7 remaining)