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

NCT04377412 | Unknown

• 1 other identifier: Maternal axiety and COVID-19
• Study Type: observational
• Target: 8,500
• Locations: 15 countries
• Sites: 17

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (17)

Albania

Other: Pandemic control measures

Australia

Other: Pandemic control measures

Czech Republic

Other: Pandemic control measures

France

Other: Pandemic control measures

Germany

Other: Pandemic control measures

Hong Kong

Other: Pandemic control measures

Israel

Other: Pandemic control measures

Italy

Other: Pandemic control measures

Lebanon

Other: Pandemic control measures

Norway

Other: Pandemic control measures

Poland

Other: Pandemic control measures

Russia

Other: Pandemic control measures

Spain

Other: Pandemic control measures

Sweden

Other: Pandemic control measures

Taiwan

Other: Pandemic control measures

Ukraine

Other: Pandemic control measures

United States

Other: Pandemic control measures

Interventions

Pandemic control measures 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.

Albania; Australia; Czech Republic; France; Germany; Hong Kong; Israel; Italy; Lebanon; Norway; Poland; Russia; Spain; Sweden; Taiwan; Ukraine; United States

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

About 10% of pregnant women experience perinatal depression globally. Untreated perinatal depression may result in adverse obstetric outcomes and is a risk factor for poor maternal health, inadequate prenatal care, and postpartum depression. In addition to the potential negative impact on pregnancy outcomes, perinatal depression is associated with disrupted maternal-infant bonding, increased irritability, and decreased activity. Children born to depressed mothers are at risk for delayed cognitive and language development, lower IQ, and increased prevalence of psychiatric and emotional problems. Depression that begins during pregnancy frequently continues or worsens after delivery.

You may qualify if:

• declaration of being pregnant
• being able to complete the survey in the available languages
• answer the screening questions
• provide informed consent for participation

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (17)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

University of Medicine Tirana

Tirana, Albania

RECRUITING

Royal Prince Alfred Hospital

Sydney, Australia

RECRUITING

Charles University

Prague, Czechia

RECRUITING

Université de Paris

Paris, France

RECRUITING

Charité - University Medicine Berlin

Berlin, Germany

RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Meir Medical Center

Kafr Saba, Israel

RECRUITING

University of Brescia

Brescia, Italy

RECRUITING

American University of Beirut

Beirut, Lebanon

RECRUITING

The Arctic University of Norway

Tromsø, Norway

RECRUITING

Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

Bydgoszcz, Poland

RECRUITING

Pomeranian Medical University

Szczecin, Poland

RECRUITING

Centre of Postgraduate Medical Education

Warsaw, Poland

RECRUITING

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

Madrid, Spain

RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

Taiji Clinic

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Coronavirus Infections; Psychological Well-Being; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Personal Satisfaction; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anna Kajdy, MD, PhD

  Centre of Postgraduate Medical Education

  STUDY CHAIR

• Michał Rabijewski, MD, PhD, Professor

  Centre of Postgraduate Medical Education

  PRINCIPAL INVESTIGATOR

• Dorota Sys, PhD

  Centre of Postgraduate Medical Education

  PRINCIPAL INVESTIGATOR

• Jan Modzelewski, MD

  Centre of Postgraduate Medical Education

  PRINCIPAL INVESTIGATOR

• Sebastian Kwiatkowski, MD, PhD

  Pomeranian Medical University Szczecin

  PRINCIPAL INVESTIGATOR

• Roksana Lewandowska, MD

  Pomeranian Medical University Szczecin

  PRINCIPAL INVESTIGATOR

• Dariusz Borowski, MD, PhD

  Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

  PRINCIPAL INVESTIGATOR

• Barbara Baranowska, PhD, RM

  Centre of Postgraduate Medical Education

  PRINCIPAL INVESTIGATOR

• Artur Pokropek, PhD, Professor

  Institute of Philosophy and Sociology of the Polish Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Urszula Ajdacka, MD

  Central Clinical Hospital of Ministry of Internal Affairs and Administration

  PRINCIPAL INVESTIGATOR

• Stepan Feduniw, MD

  Żelazna Medical Centre; Medical Faculty od Lazarski University

  PRINCIPAL INVESTIGATOR

• Maria del Mar Gil Mira, MD, PhD

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

  PRINCIPAL INVESTIGATOR

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

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Ksenia Olisova, MD, MPH

  Taiji Clinic, Taipei

  PRINCIPAL INVESTIGATOR

• Tung-Yao Chang, MD, M Med Sci

  Taiji Clinic, Taipei

  PRINCIPAL INVESTIGATOR

• Steven Shaw

  Chang Gung University

  PRINCIPAL INVESTIGATOR

• Sonia Hassan, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Jade Harris, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Orion Gliozheni, MD

  University of Medicine, Tirana

  PRINCIPAL INVESTIGATOR

• Jon Hayett, Professor

  Royal Prince Alfred Hospital, Sydney

  PRINCIPAL INVESTIGATOR

• Pavel Calda, MD, MSc, Professor

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

• Laurent J Salomon, MD, PhD, Professor

  Université de Paris

  PRINCIPAL INVESTIGATOR

• Stefan Verlohren, MD, Professor

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Liona C Poon, MBBS, MRCOG, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Tal Biron-Shental, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

• Maya Ben-Zion, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

• Federico Prefumo, MD, PhD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

• Gihad Chalouhi, MD, PhD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

• Ganesh Acharya, MD, PhD, FRCOG, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Heidi Tiller, MD, PhD

  The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

• Karine Stiberg Birkelund

  The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

• Solrun Rasmussen

  The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

• Ewa Andersson, RNM, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Kajdy, MD, PhD

CONTACT

+48663769515; akajdy@cmkp.edu.pl

Dorota Sys, PhD

CONTACT

+48222559918; dsys@cmkp.edu.pl

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 6, 2020
• Study Start: May 1, 2020
• Primary Completion: August 31, 2020
• Study Completion: October 31, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

FR (1); US (1); AU (1); DE (1); IT (1); HK (1); ES (1); CZ (1); PL (3); SE (1); AL (1); IL (1); LE (1); NO (1); TW (1)