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

May 5, 2020 updated by: Anna Kajdy, Żelazna Medical Centre, LLC

Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Albania
      • Tirana, Albania
        • Recruiting
        • University of Medicine Tirana
        • Contact:
          • Orion Gliozheni, MD
  • Australia
      • Sydney, Australia
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Jon Hyett
  • Czechia
      • Prague, Czechia
        • Recruiting
        • Charles University
        • Contact:
          • pavel Calda, MD, MSc.
  • France
      • Paris, France
        • Recruiting
        • Université de Paris
        • Contact:
          • Laurent J Salomon, MD, PhD
  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité - University Medicine Berlin
        • Contact:
          • Stefan Verlohren, MD, Professor
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
          • Liona C Poon, MBBS, MRCOG, Professor
        • Contact:
          • Equal Chen
  • Israel
      • Kafr Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:
          • Tal Biron-Shental, MD
        • Contact:
          • Maya Ben-Zion, MD
  • Italy
      • Brescia, Italy
        • Recruiting
        • University of Brescia
        • Contact:
          • Federico Prefumo, MD, PhD
  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • American University of Beirut
        • Contact:
          • Gihad Chalouhi, MD, PhD
  • Norway
      • Tromsø, Norway
        • Recruiting
        • The Arctic University of Norway
        • Contact:
          • Heidi Tiller, MD, PhD
  • Poland
      • Bydgoszcz, Poland
        • Recruiting
        • Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
        • Contact:
          • Dariusz Borowski, MD, PhD
      • Szczecin, Poland
        • Recruiting
        • Pomeranian Medical University
        • Contact:
          • Sebastian Kwiatkowski, MD, PhD
      • Warsaw, Poland
        • Recruiting
        • Centre of Postgraduate Medical Education
        • Contact:
  • Spain
      • Madrid, Spain
        • Recruiting
        • 11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"
        • Contact:
          • Maria del Mar Gil Mira, MD, PhD
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinska Institutet
        • Contact:
          • Ganesh Archaya, MD, PhD, Professor
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taiji Clinic
        • Contact:
          • Ksenia Olisova, MD, MPH
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University
        • Contact:
          • Sonia Hassan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Żelazna Medical Centre, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charles University, Czech Republic
Karolinska Institutet
Charite University, Berlin, Germany
Wayne State University
University of Tromso
Chinese University of Hong Kong
American University of Beirut Medical Center
Meir Medical Center
Pomeranian Medical University Szczecin
Nicolaus Copernicus University
Chang Gung University
Centre of Postgraduate Medical Education
Royal Prince Alfred Hospital, Sydney, Australia
Università degli Studi di Brescia
Hôpital Necker-Enfants Malades
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
University of Medicine, Tirana
Polish Academy of Sciences
Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid
Taiji Clinic, Taipei

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Maternal axiety and COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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