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

NCT04595123 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7642

Last updated 2021-09-30

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Universidad Loyola Andalucia

    collaborator OTHER
  • Beder College University. Albania

    collaborator UNKNOWN
  • Mackenzie Presbiterian University, São Paulo, Brazil

    collaborator OTHER
  • Medical University of Sofia

    collaborator OTHER
  • European University Cyprus

    collaborator OTHER
  • Groupe Hospitalier du Havre

    collaborator OTHER
  • University of Athens

    collaborator OTHER
  • Bar-Ilan University, Israel

    collaborator OTHER
  • University of Malta

    collaborator OTHER
  • Mount Carmel Health System

    collaborator OTHER
  • University of Coimbra

    collaborator OTHER
  • Universidade Católica Portuguesa

    collaborator OTHER
  • Instituto de Saude Publica da Universidade do Porto

    collaborator OTHER
  • University of Huelva

    collaborator OTHER
  • Instituto de Investigação Biomédica de Malaga. Spain

    collaborator UNKNOWN
  • Universidad Nacional de Educación a Distancia

    collaborator OTHER
  • Kırklareli University

    collaborator OTHER
  • King's College London

    collaborator OTHER
  • Universidad de Concepcion

    collaborator OTHER
  • University of Minho

    lead OTHER

Principal Investigators

  • Ana Mesquita, PhD · University of Minho

  • Emma Motrico, PhD · Universidad Loyola Andalucia

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2020-11-01
Completion
2021-02-28

Countries

  • Albania
  • Brazil
  • Bulgaria
  • Chile
  • Cyprus
  • France
  • Greece
  • Israel
  • Malta
  • Portugal
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595123 on ClinicalTrials.gov