AnxietyMindCOVIDNCT04377412
Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic
An observational study of Anxiety and Depression, run by Żelazna Medical Centre, LLC at 17 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Pregnancy Related
- How many people
- 8,500 participants
- Where
- 17 sitesin 15 countries
- Study dates
- 1 May 2020to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- declaration of being pregnant
- being able to complete the survey in the available languages
- answer the screening questions
- provide informed consent for participation
Who cannot join
- 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
Trial locations and contacts
17 sites in 15 countries.
17 sites in 15 countries
Poland3 sites, 3 recruiting
- Recruiting
Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
Bydgoszcz
Dariusz Borowski, MD, PhD
- Recruiting
Pomeranian Medical University
Szczecin
Sebastian Kwiatkowski, MD, PhD
- Recruiting
Centre of Postgraduate Medical Education
Warsaw
Anna Kajdy, MD, PhD, +489663769515, akajdy@cmkp.edu.pl
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Sonia Hassan, MD
Albania1 site, 1 recruiting
- Recruiting
University of Medicine Tirana
Tirana
Orion Gliozheni, MD
Australia1 site, 1 recruiting
- Recruiting
Royal Prince Alfred Hospital
Sydney
Jon Hyett
Czechia1 site, 1 recruiting
- Recruiting
Charles University
Prague
pavel Calda, MD, MSc.
France1 site, 1 recruiting
- Recruiting
Université de Paris
Paris
Laurent J Salomon, MD, PhD
Germany1 site, 1 recruiting
- Recruiting
Charité - University Medicine Berlin
Berlin
Stefan Verlohren, MD, Professor
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Liona C Poon, MBBS, MRCOG, Professor
Equal Chen
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kafr Saba
Tal Biron-Shental, MD
Maya Ben-Zion, MD
Italy1 site, 1 recruiting
- Recruiting
University of Brescia
Brescia
Federico Prefumo, MD, PhD
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut
Beirut
Gihad Chalouhi, MD, PhD
Norway1 site, 1 recruiting
- Recruiting
The Arctic University of Norway
Tromsø
Heidi Tiller, MD, PhD
Spain1 site, 1 recruiting
- Recruiting
11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"
Madrid
Maria del Mar Gil Mira, MD, PhD
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm
Ganesh Archaya, MD, PhD, Professor
Taiwan1 site, 1 recruiting
- Recruiting
Taiji Clinic
Taipei
Ksenia Olisova, MD, MPH
About this study
Official title: 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.
- Conditions
- Anxiety, Depression, Pregnancy Related
- Being tested
- Pandemic control measures
- Keywords
- coronavirus, mental health, pregnancy, anxiety, depression, COVID-19, pandemic
- Medical subject headings
- Anxiety Disorders, Depression, Coronavirus Infections, Psychological Well-Being, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemic control measuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Albania | Not described Receives: Other: Pandemic control measures | |
| Australia | Not described Receives: Other: Pandemic control measures | |
| Czech Republic | Not described Receives: Other: Pandemic control measures | |
| France | Not described Receives: Other: Pandemic control measures | |
| Germany | Not described Receives: Other: Pandemic control measures | |
| Hong Kong | Not described Receives: Other: Pandemic control measures | |
| Israel | Not described Receives: Other: Pandemic control measures | |
| Italy | Not described Receives: Other: Pandemic control measures | |
| Lebanon | Not described Receives: Other: Pandemic control measures | |
| Norway | Not described Receives: Other: Pandemic control measures | |
| Poland | Not described Receives: Other: Pandemic control measures | |
| Russia | Not described Receives: Other: Pandemic control measures | |
| Spain | Not described Receives: Other: Pandemic control measures | |
| Sweden | Not described Receives: Other: Pandemic control measures | |
| Taiwan | Not described Receives: Other: Pandemic control measures | |
| Ukraine | Not described Receives: Other: Pandemic control measures | |
| United States | Not described Receives: Other: Pandemic control measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 May 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 8,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Anna Kajdy, Centre of Postgraduate Medical Education
- Investigators
- Anna Kajdy, MD, PhD, Study chair, Centre of Postgraduate Medical EducationMichał Rabijewski, MD, PhD, Professor, Principal investigator, Centre of Postgraduate Medical EducationDorota Sys, PhD, Principal investigator, Centre of Postgraduate Medical EducationJan Modzelewski, MD, Principal investigator, Centre of Postgraduate Medical EducationSebastian Kwiatkowski, MD, PhD, Principal investigator, Pomeranian Medical University SzczecinRoksana Lewandowska, MD, Principal investigator, Pomeranian Medical University SzczecinDariusz Borowski, MD, PhD, Principal investigator, Nicolaus Copernicus University in Toruń, Collegium Medicum in BydgoszczBarbara Baranowska, PhD, RM, Principal investigator, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377412
- Sponsor's protocol ID
- Maternal axiety and COVID-19
- Acronym
- MindCOVID
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT04377412
- Acronym / sponsor ID
- MindCOVID / Maternal axiety and COVID-19
- Conditions
- Anxiety, Depression, Pregnancy Related
- Keywords
- coronavirus, mental health, pregnancy, anxiety, depression, COVID-19, pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,500 participants (estimated)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- 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
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- declaration of being pregnant
- being able to complete the survey in the available languages
- answer the screening questions
- provide informed consent for participation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pandemic control measuresPopulation 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. | Other | Albania, Australia, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Lebanon, Norway, Poland, Russia, Spain, Sweden, Taiwan, Ukraine, United States |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Kajdy, MD, PhD study chair
Centre of Postgraduate Medical Education
Michał Rabijewski, MD, PhD, Professor principal investigator
Centre of Postgraduate Medical Education
Dorota Sys, PhD principal investigator
Centre of Postgraduate Medical Education
17 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Żelazna Medical Centre, LLC at 17 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Poland, United States, Albania, Australia, Czechia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Kajdy, MD, PhD (+48663769515, akajdy@cmkp.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.