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Impact of COVID-19 Pandemic in Perinatal Mental Health (RISEUP-PPD-COVID-19)

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ClinicalTrials.gov Identifier: NCT04595123
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
Universidad Loyola Andalucia
Beder College University. Albania
Mackenzie Presbiterian University, São Paulo, Brazil
Medical University of Sofia
European University Cyprus
Groupe Hospitalier du Havre
University of Athens
Bar-Ilan University, Israel
University of Malta
Mount Carmel Health System
University of Coimbra
Universidade Católica Portuguesa
Instituto de Saude Publica da Universidade do Porto
University of Huelva
Instituto de Investigação Biomédica de Malaga. Spain
Universidad Nacional de Educación a Distancia
Kırklareli University
King's College London
Universidad de Concepcion
Information provided by (Responsible Party):
Ana Mesquita, University of Minho

Brief Summary:
Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

Condition or disease
Post Traumatic Stress Disorder Depression Anxiety Psychological Distress

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Study Type : Observational
Estimated Enrollment : 3900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of COVID-19 Pandemic in Perinatal Mental Health
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: June 2020- June 2021 ]

    Number of depressive symptoms evaluated by Edinburgh Postnatal Depression Scale (EPDS).

    Scores range from 0 to 30. Higher scores mean worse outcome


  2. Posttraumatic Stress Disorder [ Time Frame: June 2020- June 2021 ]
    Number of Post-Traumatic Stress Disorders (PTSD) symptoms evaluated by check list of DSM-5. HIgher number of symptoms mean worse outcomes

  3. Anxiety symptoms [ Time Frame: June 2020- June 2021 ]
    Number of anxiety symptoms evaluated by General Anxiety Disorder questionnaire (GAD 7). Scores range from 0 to 21. Higher scores mean worse outcomes.



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
The study population is pregnant women and new mothers with an infant under six months of age. The rationale is to evaluate during the six-month follow-up the "peripartum period", from pregnancy to one year following childbirth
Criteria

Inclusion Criteria:

  • Pregnant or biological mother of a child six months old or younger
  • 18 years of age or older
  • Live in one of the countries of the study
  • Accept to participate in the study

Exclusion Criteria:

  • Not pregnant and not biological mother of a child 6 months old or younger
  • Younger than 18 years old
  • Not live in one of the countries of the study

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): NCT04595123


Contacts
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Contact: Ana Mesquita, PhD +351 253604613 ana.mesquita@psi.uminho.pt
Contact: Ana Rita Carlos +351 253604503 a.carlos@gap.uminho.pt

Locations
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Albania
Beder College University Recruiting
Tirana, Albania
Contact: Erilda Ajaz, PhD       eajaz@beder.edu.al   
Brazil
Universidade Presbiteriana Mackenzie Recruiting
São Paulo, Brazil
Contact: Vera Mateus, PhD       vera.mateus@mackenzista.com.br   
Bulgaria
Sofia University Recruiting
Sofia, Bulgaria
Contact: Camellia Hancheva, PhD       hancheva@phls.uni-sofia.bg   
Chile
Universidad de Concepción Recruiting
Concepción, Chile
Contact: Sandra M. Saldivia, PhD    (56) 412204715    ssaldivi@udec.cl   
Cyprus
European University Cyprus Recruiting
Nicosia, Cyprus
Contact: Andry Christoforou, PhD    +357 22 713000    a.christoforou@euc.ac.cy   
France
Groupe Hospitalier du Havre Not yet recruiting
Le Havre, France
Contact: Angelique Picard, PhD    02.32.73.48.56    angelique.picard@ch-havre.fr   
Greece
University of Athens Recruiting
Athens, Greece
Contact: Eleni Vousoura, PhD       eleni.vousoura@gmail.com   
Israel
Bar-Ilan University Recruiting
Ramat Gan, Israel
Contact: Rena Bina, PhD    972-3-7384547    rena.bina@biu.ac.il   
Malta
University of Malta Recruiting
Imsida, Malta
Contact: Ethel Felice, Dr       ethel.felice@um.edu.mt   
Portugal
Universidade do Minho Recruiting
Braga, Portugal
Contact: Ana Mesquita, PhD    +351 253604613    ana.mesquita@psi.uminho.pt   
Spain
Universidad Loyola Andalucia Recruiting
Sevilla, Spain
Contact: Emma Motrico, PhD    +34955641600    emotrico@uloyola.es   
Sub-Investigator: Sara Dominguez, PhD         
Turkey
Kırklareli Üniversitesi Recruiting
Kırklareli, Turkey
Contact: Pelin Dikmen-Yildiz, PhD         
Contact       pelindikmen@gmail.com   
United Kingdom
King'S College London Recruiting
London, United Kingdom
Contact: Claire Wilson, PhD       claire.1.wilson@kcl.ac.uk   
Sponsors and Collaborators
University of Minho
Universidad Loyola Andalucia
Beder College University. Albania
Mackenzie Presbiterian University, São Paulo, Brazil
Medical University of Sofia
European University Cyprus
Groupe Hospitalier du Havre
University of Athens
Bar-Ilan University, Israel
University of Malta
Mount Carmel Health System
University of Coimbra
Universidade Católica Portuguesa
Instituto de Saude Publica da Universidade do Porto
University of Huelva
Instituto de Investigação Biomédica de Malaga. Spain
Universidad Nacional de Educación a Distancia
Kırklareli University
King's College London
Universidad de Concepcion
Investigators
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Principal Investigator: Ana Mesquita, PhD University of Minho
Principal Investigator: Emma Motrico, PhD Universidad Loyola Andalucia
Additional Information:
Publications:
World Health Organization (2020). WHO guidelines on Intrapartum care for a positive childbirth experience and Interim guidance on Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf
Royal College of Obstetricians & Gynaecologists: Coronavirus (COVID-19) infection and pregnancy https://www.rcog.org.uk/globalassets/documents/guidelines/2020-04-03-coronavirus-covid-19-infection-in-pregnancy.pdf
Wu, Y. T., Zhang, C., Liu, H., Duan, C. C., Li, C., Fan, J. X., ... & Guo, Y. (2020). Perinatal Depression of Women Along with 2019 Novel Coronavirus Breakout in China. Available at SSRN: https://ssrn.com/abstract=3539359 or http://dx.doi.org/10.2139/ssrn.3539359
Thomason, M.E., Graham, A., VanTieghem, M.R. (2020). The COPE-IS: Coronavirus Perinatal Experiences - Impact Survey. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/.
Thomason, M.E., Graham, A., Smyser, C.D., Rogers, C.E. (2020). The COPE-IU: Coronavirus Perinatal Experiences - Impact Update. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/
Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems
Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist for DSM-5 (PCL-5) - Extended Criterion A [Measurement instrument]. Available from https://www.ptsd.va.gov/

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Responsible Party: Ana Mesquita, PhD, University of Minho
ClinicalTrials.gov Identifier: NCT04595123    
Other Study ID Numbers: RISEUP-PPD-COVID-19
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Ana Mesquita, University of Minho:
Perinatal mental health
Women
Anxiety
Depression
COVID-19
Additional relevant MeSH terms:
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Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders