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

NCT ID: NCT04377412

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

8500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-10-31

Brief Summary

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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

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Conditions

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Anxiety Depression Pregnancy Related

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Albania

Pandemic control measures

Intervention Type OTHER

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.

Australia

Pandemic control measures

Intervention Type OTHER

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.

Czech Republic

Pandemic control measures

Intervention Type OTHER

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.

France

Pandemic control measures

Intervention Type OTHER

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.

Germany

Pandemic control measures

Intervention Type OTHER

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.

Hong Kong

Pandemic control measures

Intervention Type OTHER

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.

Israel

Pandemic control measures

Intervention Type OTHER

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.

Italy

Pandemic control measures

Intervention Type OTHER

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.

Lebanon

Pandemic control measures

Intervention Type OTHER

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.

Norway

Pandemic control measures

Intervention Type OTHER

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.

Poland

Pandemic control measures

Intervention Type OTHER

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.

Russia

Pandemic control measures

Intervention Type OTHER

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.

Spain

Pandemic control measures

Intervention Type OTHER

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.

Sweden

Pandemic control measures

Intervention Type OTHER

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.

Taiwan

Pandemic control measures

Intervention Type OTHER

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.

Ukraine

Pandemic control measures

Intervention Type OTHER

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.

United States

Pandemic control measures

Intervention Type OTHER

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.

Interventions

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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 Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Medicine, Tirana

OTHER

Sponsor Role collaborator

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role collaborator

American University of Beirut Medical Center

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Pomeranian Medical University Szczecin

OTHER

Sponsor Role collaborator

Nicolaus Copernicus University

OTHER

Sponsor Role collaborator

Centre of Postgraduate Medical Education

OTHER

Sponsor Role collaborator

Polish Academy of Sciences

OTHER

Sponsor Role collaborator

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

OTHER

Sponsor Role collaborator

Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid

UNKNOWN

Sponsor Role collaborator

Taiji Clinic, Taipei

UNKNOWN

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role collaborator

Chang Gung University

OTHER

Sponsor Role collaborator

University of Tromso

OTHER

Sponsor Role collaborator

Żelazna Medical Centre, LLC

OTHER

Sponsor Role lead

Responsible Party

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Anna Kajdy

Md, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Kajdy, MD, PhD

Role: STUDY_CHAIR

Centre of Postgraduate Medical Education

Michał Rabijewski, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre of Postgraduate Medical Education

Dorota Sys, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre of Postgraduate Medical Education

Jan Modzelewski, MD

Role: PRINCIPAL_INVESTIGATOR

Centre of Postgraduate Medical Education

Sebastian Kwiatkowski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pomeranian Medical University Szczecin

Roksana Lewandowska, MD

Role: PRINCIPAL_INVESTIGATOR

Pomeranian Medical University Szczecin

Dariusz Borowski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

Barbara Baranowska, PhD, RM

Role: PRINCIPAL_INVESTIGATOR

Centre of Postgraduate Medical Education

Artur Pokropek, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Philosophy and Sociology of the Polish Academy of Sciences

Urszula Ajdacka, MD

Role: PRINCIPAL_INVESTIGATOR

Central Clinical Hospital of Ministry of Internal Affairs and Administration

Stepan Feduniw, MD

Role: PRINCIPAL_INVESTIGATOR

Żelazna Medical Centre; Medical Faculty od Lazarski University

Maria del Mar Gil Mira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"

Simone Schwank, PhD M.S. M.A. Msc. Clinical Ps

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Ksenia Olisova, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Taiji Clinic, Taipei

Tung-Yao Chang, MD, M Med Sci

Role: PRINCIPAL_INVESTIGATOR

Taiji Clinic, Taipei

Steven Shaw

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Sonia Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Jade Harris, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Orion Gliozheni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine, Tirana

Jon Hayett, Professor

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital, Sydney

Pavel Calda, MD, MSc, Professor

Role: PRINCIPAL_INVESTIGATOR

Charles University

Laurent J Salomon, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Université de Paris

Stefan Verlohren, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Liona C Poon, MBBS, MRCOG, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Tal Biron-Shental, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Maya Ben-Zion, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Federico Prefumo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Gihad Chalouhi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Ganesh Acharya, MD, PhD, FRCOG, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Heidi Tiller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Arctic University of Norway

Karine Stiberg Birkelund

Role: PRINCIPAL_INVESTIGATOR

The Arctic University of Norway

Solrun Rasmussen

Role: PRINCIPAL_INVESTIGATOR

The Arctic University of Norway

Ewa Andersson, RNM, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status RECRUITING

University of Medicine Tirana

Tirana, , Albania

Site Status RECRUITING

Royal Prince Alfred Hospital

Sydney, , Australia

Site Status RECRUITING

Charles University

Prague, , Czechia

Site Status RECRUITING

Université de Paris

Paris, , France

Site Status RECRUITING

Charité - University Medicine Berlin

Berlin, , Germany

Site Status RECRUITING

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Meir Medical Center

Kafr Saba, , Israel

Site Status RECRUITING

University of Brescia

Brescia, , Italy

Site Status RECRUITING

American University of Beirut

Beirut, , Lebanon

Site Status RECRUITING

The Arctic University of Norway

Tromsø, , Norway

Site Status RECRUITING

Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

Bydgoszcz, , Poland

Site Status RECRUITING

Pomeranian Medical University

Szczecin, , Poland

Site Status RECRUITING

Centre of Postgraduate Medical Education

Warsaw, , Poland

Site Status RECRUITING

11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"

Madrid, , Spain

Site Status RECRUITING

Karolinska Institutet

Stockholm, , Sweden

Site Status RECRUITING

Taiji Clinic

Taipei, , Taiwan

Site Status RECRUITING

Countries

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

Central Contacts

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Anna Kajdy, MD, PhD

Role: CONTACT

+48663769515

Dorota Sys, PhD

Role: CONTACT

+48222559918

Facility Contacts

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Sonia Hassan, MD

Role: primary

Orion Gliozheni, MD

Role: primary

Jon Hyett

Role: primary

pavel Calda, MD, MSc.

Role: primary

Laurent J Salomon, MD, PhD

Role: primary

Stefan Verlohren, MD, Professor

Role: primary

Liona C Poon, MBBS, MRCOG, Professor

Role: primary

Equal Chen

Role: backup

Tal Biron-Shental, MD

Role: primary

Maya Ben-Zion, MD

Role: backup

Federico Prefumo, MD, PhD

Role: primary

Gihad Chalouhi, MD, PhD

Role: primary

Heidi Tiller, MD, PhD

Role: primary

Dariusz Borowski, MD, PhD

Role: primary

Sebastian Kwiatkowski, MD, PhD

Role: primary

Anna Kajdy, MD, PhD

Role: primary

+489663769515

Maria del Mar Gil Mira, MD, PhD

Role: primary

Ganesh Archaya, MD, PhD, Professor

Role: primary

Ksenia Olisova, MD, MPH

Role: primary

Other Identifiers

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Maternal axiety and COVID-19

Identifier Type: -

Identifier Source: org_study_id

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