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Status unknownNCT04377412MindCOVIDUpdated May 6, 2020

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

An observational study in Anxiety, Depression and Pregnancy Related, sponsored by Żelazna Medical Centre, LLC. Status unknown at 17 sites in 15 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-06.

Primary conditionDepressionRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Depression.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Żelazna Medical Centre, LLC · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
8,500
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Anxiety
  • Depression
  • Pregnancy Related

Keywords

  • coronavirus
  • mental health
  • pregnancy
  • anxiety
  • depression
  • COVID-19
  • pandemic
03

In context

Depression Reclassified

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's planned enrollment of 8,500 is above the median of 175 across 1,257 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Żelazna Medical Centre, LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • not providing online 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
8,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPandemic 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 months

  2. 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

    Time frame: 4 months

07

Study locations

17 of 17 sites recruiting
  • Wayne State University
    Detroit, Michigan 48201, United States
    Recruiting
    • Sonia Hassan, MD · Contact
  • University of Medicine Tirana
    Tirana, Albania
    Recruiting
    • Orion Gliozheni, MD · Contact
  • Royal Prince Alfred Hospital
    Sydney, Australia
    Recruiting
    • Jon Hyett · Contact
  • Charles University
    Prague, Czechia
    Recruiting
    • pavel Calda, MD, MSc. · Contact
  • Université de Paris
    Paris, France
    Recruiting
    • Laurent J Salomon, MD, PhD · Contact
  • Charité - University Medicine Berlin
    Berlin, Germany
    Recruiting
    • Stefan Verlohren, MD, Professor · Contact
  • The Chinese University of Hong Kong
    Hong Kong, Hong Kong
    Recruiting
    • Liona C Poon, MBBS, MRCOG, Professor · Contact
    • Equal Chen · Contact
  • Meir Medical Center
    Kafr Saba, Israel
    Recruiting
    • Tal Biron-Shental, MD · Contact
    • Maya Ben-Zion, MD · Contact
  • University of Brescia
    Brescia, Italy
    Recruiting
    • Federico Prefumo, MD, PhD · Contact
  • American University of Beirut
    Beirut, Lebanon
    Recruiting
    • Gihad Chalouhi, MD, PhD · Contact
  • The Arctic University of Norway
    Tromsø, Norway
    Recruiting
    • Heidi Tiller, MD, PhD · Contact
  • Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
    Bydgoszcz, Poland
    Recruiting
    • Dariusz Borowski, MD, PhD · Contact
  • Pomeranian Medical University
    Szczecin, Poland
    Recruiting
    • Sebastian Kwiatkowski, MD, PhD · Contact
  • 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
    • Maria del Mar Gil Mira, MD, PhD · Contact
  • Karolinska Institutet
    Stockholm, Sweden
    Recruiting
    • Ganesh Archaya, MD, PhD, Professor · Contact
  • Taiji Clinic
    Taipei, Taiwan
    Recruiting
    • Ksenia Olisova, MD, MPH · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2020 (actual). Primary completion is estimated for Aug 2020, 3 months after the start.

Of 460 non-industry observational studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's planned 3 months is below that.

Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 13 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2020
First posted
May 6, 2020
StartActual
May 1, 2020
Primary completionEst.
Aug 31, 2020
CompletionEst.
Oct 31, 2020
Last update
May 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04377412
Lead sponsor
Żelazna Medical Centre, LLC
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
Anna Kajdy (Md, PhD, Centre of Postgraduate Medical Education) — Principal investigator
First posted
May 6, 2020
Start date
May 1, 2020
Primary completion
Aug 31, 2020 (estimated)
Completion
Oct 31, 2020 (estimated)
Last update
May 6, 2020

Study contacts

Anna Kajdy, MD, PhD
Contact
akajdy@cmkp.edu.pl
+48663769515
Dorota Sys, PhD
Contact
dsys@cmkp.edu.pl
+48222559918
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
Jan Modzelewski, MD
principal investigator · Centre of Postgraduate Medical Education
Sebastian Kwiatkowski, MD, PhD
principal investigator · Pomeranian Medical University Szczecin
Roksana Lewandowska, MD
principal investigator · Pomeranian Medical University Szczecin
Dariusz Borowski, MD, PhD
principal investigator · Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
Barbara Baranowska, PhD, RM
principal investigator · Centre of Postgraduate Medical Education
Artur Pokropek, PhD, Professor
principal investigator · Institute of Philosophy and Sociology of the Polish Academy of Sciences
Urszula Ajdacka, MD
principal investigator · Central Clinical Hospital of Ministry of Internal Affairs and Administration
Stepan Feduniw, MD
principal investigator · Żelazna Medical Centre; Medical Faculty od Lazarski University
Maria del Mar Gil Mira, MD, PhD
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
principal investigator · Karolinska Institutet
Ksenia Olisova, MD, MPH
principal investigator · Taiji Clinic, Taipei
Tung-Yao Chang, MD, M Med Sci
principal investigator · Taiji Clinic, Taipei
Steven Shaw
principal investigator · Chang Gung University
Sonia Hassan, MD
principal investigator · Wayne State University
Jade Harris, MD
principal investigator · Wayne State University
Orion Gliozheni, MD
principal investigator · University of Medicine, Tirana
Jon Hayett, Professor
principal investigator · Royal Prince Alfred Hospital, Sydney
Pavel Calda, MD, MSc, Professor
principal investigator · Charles University
Laurent J Salomon, MD, PhD, Professor
principal investigator · Université de Paris
Stefan Verlohren, MD, Professor
principal investigator · Charite University, Berlin, Germany
Liona C Poon, MBBS, MRCOG, Professor
principal investigator · Chinese University of Hong Kong
Tal Biron-Shental, MD
principal investigator · Meir Medical Center
Maya Ben-Zion, MD
principal investigator · Meir Medical Center
Federico Prefumo, MD, PhD
principal investigator · Università degli Studi di Brescia
Gihad Chalouhi, MD, PhD
principal investigator · American University of Beirut Medical Center
Ganesh Acharya, MD, PhD, FRCOG, Professor
principal investigator · Karolinska Institutet
Heidi Tiller, MD, PhD
principal investigator · The Arctic University of Norway
Karine Stiberg Birkelund
principal investigator · The Arctic University of Norway
Solrun Rasmussen
principal investigator · The Arctic University of Norway
Ewa Andersson, RNM, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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