Impact of COVID-19 Pandemic in Perinatal Mental Health (RISEUP-PPD-COVID-19)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04595123 |
Recruitment Status :
Recruiting
First Posted : October 20, 2020
Last Update Posted : October 27, 2020
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Condition or disease |
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Post Traumatic Stress Disorder Depression Anxiety Psychological Distress |

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 |

- 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
- 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
- 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.

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.
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 |
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

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
Contact: Ana Mesquita, PhD | +351 253604613 | ana.mesquita@psi.uminho.pt | |
Contact: Ana Rita Carlos | +351 253604503 | a.carlos@gap.uminho.pt |
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 |
Principal Investigator: | Ana Mesquita, PhD | University of Minho | |
Principal Investigator: | Emma Motrico, PhD | Universidad Loyola Andalucia |
Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Perinatal mental health Women Anxiety Depression COVID-19 |
Depression Stress Disorders, Traumatic Stress Disorders, Post-Traumatic |
Behavioral Symptoms Mental Disorders Trauma and Stressor Related Disorders |