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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377412
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
University of Medicine, Tirana
Royal Prince Alfred Hospital, Sydney, Australia
Charles University, Czech Republic
Hôpital Necker-Enfants Malades
Charite University, Berlin, Germany
Chinese University of Hong Kong
Meir Medical Center
Università degli Studi di Brescia
American University of Beirut Medical Center
Karolinska Institutet
Pomeranian Medical University Szczecin
Nicolaus Copernicus University
Centre of Postgraduate Medical Education
Polish Academy of Sciences
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid
Taiji Clinic, Taipei
Wayne State University
Chang Gung University
University of Tromso
Information provided by (Responsible Party):
Anna Kajdy, Centre of Postgraduate Medical Education

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.

Condition or disease Intervention/treatment
Anxiety Depression Pregnancy Related Other: Pandemic control measures

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Study Type : Observational
Estimated Enrollment : 8500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Albania 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.

Australia 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.

Czech Republic 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.

France 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.

Germany 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.

Hong Kong 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.

Israel 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.

Italy 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.

Lebanon 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.

Norway 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.

Poland 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.

Russia 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.

Spain 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.

Sweden 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.

Taiwan 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.

Ukraine 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.

United States 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.




Primary Outcome Measures :
  1. Anxiety [ Time Frame: 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

  2. Depression [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377412


Contacts
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Contact: Anna Kajdy, MD, PhD +48663769515 akajdy@cmkp.edu.pl
Contact: Dorota Sys, PhD +48222559918 dsys@cmkp.edu.pl

Locations
Show Show 17 study locations
Sponsors and Collaborators
Żelazna Medical Centre, LLC
University of Medicine, Tirana
Royal Prince Alfred Hospital, Sydney, Australia
Charles University, Czech Republic
Hôpital Necker-Enfants Malades
Charite University, Berlin, Germany
Chinese University of Hong Kong
Meir Medical Center
Università degli Studi di Brescia
American University of Beirut Medical Center
Karolinska Institutet
Pomeranian Medical University Szczecin
Nicolaus Copernicus University
Centre of Postgraduate Medical Education
Polish Academy of Sciences
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid
Taiji Clinic, Taipei
Wayne State University
Chang Gung University
University of Tromso
Investigators
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Study Chair: Anna Kajdy, MD, PhD Centre of Postgraduate Medical Education
Principal Investigator: 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
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
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Responsible Party: Anna Kajdy, Md, PhD, Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier: NCT04377412    
Other Study ID Numbers: Maternal axiety and COVID-19
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Kajdy, Centre of Postgraduate Medical Education:
coronavirus
mental health
pregnancy
anxiety
depression
COVID-19
pandemic
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders