Clinical trial NCT04377412: Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic
Official title: Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Depression
Pregnancy Related
Keywords: coronavirus
mental health
pregnancy
anxiety
depression
COVID-19
pandemic
Lead sponsor: Żelazna Medical Centre, LLC
Sponsor class: OTHER
Collaborators: name: University of Medicine, Tirana
name: Royal Prince Alfred Hospital, Sydney, Australia
name: Charles University, Czech Republic
name: Hôpital Necker-Enfants Malades
name: Charite University, Berlin, Germany
name: Chinese University of Hong Kong
name: Meir Medical Center
name: Università degli Studi di Brescia
name: American University of Beirut Medical Center
name: Karolinska Institutet
name: Pomeranian Medical University Szczecin
name: Nicolaus Copernicus University
name: Centre of Postgraduate Medical Education
name: Polish Academy of Sciences
name: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
name: Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid
name: Taiji Clinic, Taipei
name: Wayne State University
name: Chang Gung University
name: University of Tromso
First posted: 2020-05-06
Enrollment: 8500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Anxiety
timeFrame: 4 months
measure: Depression
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Tirana
country: Albania
facility: University of Medicine Tirana
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Prague
country: Czechia
facility: Charles University
city: Paris
country: France
facility: Université de Paris
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Kafr Saba
country: Israel
facility: Meir Medical Center
city: Brescia
country: Italy
facility: University of Brescia
city: Beirut
country: Lebanon
facility: American University of Beirut
city: Tromsø
country: Norway
facility: The Arctic University of Norway
city: Bydgoszcz
country: Poland
facility: Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
city: Szczecin
country: Poland
facility: Pomeranian Medical University
city: Warsaw
country: Poland
facility: Centre of Postgraduate Medical Education
city: Madrid
country: Spain
facility: 11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Taipei
country: Taiwan
facility: Taiji Clinic
Study officials:
affiliation: Centre of Postgraduate Medical Education
name: Anna Kajdy, MD, PhD
role: STUDY_CHAIR
affiliation: Centre of Postgraduate Medical Education
name: Michał Rabijewski, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre of Postgraduate Medical Education
name: Dorota Sys, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre of Postgraduate Medical Education
name: Jan Modzelewski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pomeranian Medical University Szczecin
name: Sebastian Kwiatkowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pomeranian Medical University Szczecin
name: Roksana Lewandowska, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
name: Dariusz Borowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre of Postgraduate Medical Education
name: Barbara Baranowska, PhD, RM
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Philosophy and Sociology of the Polish Academy of Sciences
name: Artur Pokropek, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Clinical Hospital of Ministry of Internal Affairs and Administration
name: Urszula Ajdacka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Żelazna Medical Centre; Medical Faculty od Lazarski University
name: Stepan Feduniw, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"
name: Maria del Mar Gil Mira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Simone Schwank, PhD M.S. M.A. Msc. Clinical Ps
role: PRINCIPAL_INVESTIGATOR
affiliation: Taiji Clinic, Taipei
name: Ksenia Olisova, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Taiji Clinic, Taipei
name: Tung-Yao Chang, MD, M Med Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung University
name: Steven Shaw
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Sonia Hassan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Jade Harris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine, Tirana
name: Orion Gliozheni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Prince Alfred Hospital, Sydney
name: Jon Hayett, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University
name: Pavel Calda, MD, MSc, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Paris
name: Laurent J Salomon, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Stefan Verlohren, MD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Liona C Poon, MBBS, MRCOG, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center
name: Tal Biron-Shental, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center
name: Maya Ben-Zion, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Brescia
name: Federico Prefumo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: American University of Beirut Medical Center
name: Gihad Chalouhi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Ganesh Acharya, MD, PhD, FRCOG, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Arctic University of Norway
name: Heidi Tiller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Arctic University of Norway
name: Karine Stiberg Birkelund
role: PRINCIPAL_INVESTIGATOR
affiliation: The Arctic University of Norway
name: Solrun Rasmussen
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Ewa Andersson, RNM, PhD
role: PRINCIPAL_INVESTIGATOR
References: