Recruiting

Observational Study

Sponsor:

Żelazna Medical Centre, LLC

Code:

NCT04377412

Conditions

Anxiety

Depression

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pandemic control measures

Study Details

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.

Conditions

Anxiety

Depression

Pregnancy Related

Study ID

NCT04377412

Start date

May 1, 2020

Status verified date

May, 2020

Completion date

Oct 31, 2020

Anticipated

Primary completion date

Aug 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

8500 participants

Anticipated

Interventions and Outcome Measures

Arms

Albania

Australia

Czech Republic

France

Germany

Hong Kong

Israel

Italy

Lebanon

Norway

Poland

Russia

Spain

Sweden

Taiwan

Ukraine

United States

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.

Primary outcome measure

  • Anxiety [ Time Frame: 4 months ]
  • Depression [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

More Information

Sponsor

Żelazna Medical Centre, LLC

Last update posted

May 6, 2020

Last verified

May, 2020

Keywords

  • coronavirus
  • mental health
  • pregnancy
  • anxiety
  • depression
  • COVID-19
  • pandemic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Żelazna Medical Centre, LLC on 2020-05-06.