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

NCT04595123 | Completed

• 1 other identifier: RISEUP-PPD-COVID-19
• Study Type: observational
• Target: 7,642
• Locations: 13 countries
• Sites: 13

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.

Conditions

Post Traumatic Stress Disorder; Depression; Anxiety; Psychological Distress

Keywords

Perinatal mental health; Women; Anxiety; Depression; COVID-19

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

  Number of depressive symptoms evaluated by Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30. Higher scores mean worse outcome

  June 2020- June 2021

• Posttraumatic Stress Disorder

  Number of Post-Traumatic Stress Disorders (PTSD) symptoms evaluated by check list of DSM-5. HIgher number of symptoms mean worse outcomes

  June 2020- June 2021

• Anxiety symptoms

  Number of anxiety symptoms evaluated by General Anxiety Disorder questionnaire (GAD 7). Scores range from 0 to 21. Higher scores mean worse outcomes.

  June 2020- June 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minho: lead
• Universidad Loyola Andalucia: collaborator
• Beder College University. Albania: collaborator
• Mackenzie Presbiterian University, São Paulo, Brazil: collaborator
• Medical University of Sofia: collaborator
• European University Cyprus: collaborator
• Groupe Hospitalier du Havre: collaborator
• University of Athens: collaborator
• Bar-Ilan University, Israel: collaborator
• University of Malta: collaborator
• Mount Carmel Health System: collaborator
• University of Coimbra: collaborator
• Universidade Católica Portuguesa: collaborator
• Instituto de Saude Publica da Universidade do Porto: collaborator
• University of Huelva: collaborator
• Instituto de Investigação Biomédica de Malaga. Spain: collaborator
• Universidad Nacional de Educación a Distancia: collaborator
• Kırklareli University: collaborator
• King's College London: collaborator
• Universidad de Concepcion: collaborator

Study Sites (13)

Beder College University

Tirana, Albania

Location

Universidade Presbiteriana Mackenzie

São Paulo, Brazil

Location

Sofia University

Sofia, Bulgaria

Location

Universidad de Concepción

Concepción, Chile

Location

European University Cyprus

Nicosia, Cyprus

Location

Groupe Hospitalier du Havre

Le Havre, France

Location

University of Athens

Athens, Greece

Location

Bar-Ilan University

Ramat Gan, Israel

Location

University of Malta

Msida, Malta

Location

Universidade do Minho

Braga, Portugal

Location

Universidad Loyola Andalucia

Seville, Spain

Location

Kırklareli Üniversitesi

Kırklareli, Turkey (Türkiye)

Location

King'S College London

London, United Kingdom

Location

Related Publications (23)

• Yu N, Li W, Kang Q, Xiong Z, Wang S, Lin X, Liu Y, Xiao J, Liu H, Deng D, Chen S, Zeng W, Feng L, Wu J. Clinical features and obstetric and neonatal outcomes of pregnant patients with COVID-19 in Wuhan, China: a retrospective, single-centre, descriptive study. Lancet Infect Dis. 2020 May;20(5):559-564. doi: 10.1016/S1473-3099(20)30176-6. Epub 2020 Mar 24.

  PMID: 32220284 BACKGROUND

• 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

  BACKGROUND

• National Collaborating Centre for Women's and Children's Health (UK). Fertility: Assessment and Treatment for People with Fertility Problems. London: Royal College of Obstetricians & Gynaecologists; 2013 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK247932/

  PMID: 25340218 BACKGROUND

• Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.

  PMID: 29449816 BACKGROUND

• Shorey S, Chee CYI, Ng ED, Chan YH, Tam WWS, Chong YS. Prevalence and incidence of postpartum depression among healthy mothers: A systematic review and meta-analysis. J Psychiatr Res. 2018 Sep;104:235-248. doi: 10.1016/j.jpsychires.2018.08.001. Epub 2018 Aug 3.

  PMID: 30114665 BACKGROUND

• Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94:e202004033. Spanish.

  PMID: 32382001 BACKGROUND

• Moraes EV, Toledo OR, David FL, Godoi BN, Monteiro KA, Deluqui TC, Teixeira TW, Carvalho AL, Avelino MM. Implications of the clinical gestational diagnosis of ZIKV infection in the manifestation of symptoms of postpartum depression: a case-control study. BMC Psychiatry. 2019 Jun 26;19(1):199. doi: 10.1186/s12888-019-2157-9.

  PMID: 31242891 BACKGROUND

• Dos Santos Oliveira SJG, Dos Reis CL, Cipolotti R, Gurgel RQ, Santos VS, Martins-Filho PRS. Anxiety, depression, and quality of life in mothers of newborns with microcephaly and presumed congenital Zika virus infection: a follow-up study during the first year after birth. Arch Womens Ment Health. 2017 Jun;20(3):473-475. doi: 10.1007/s00737-017-0724-y. Epub 2017 Apr 21. No abstract available.

  PMID: 28429099 BACKGROUND

• Lebel C, MacKinnon A, Bagshawe M, Tomfohr-Madsen L, Giesbrecht G. Elevated depression and anxiety symptoms among pregnant individuals during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:5-13. doi: 10.1016/j.jad.2020.07.126. Epub 2020 Aug 1.

  PMID: 32777604 BACKGROUND

• 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

  BACKGROUND

• 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/.

  BACKGROUND

• 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/

  BACKGROUND

• Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems

  BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• 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/

  BACKGROUND

• Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017 Feb 7;15(1):8. doi: 10.1186/s12961-016-0164-6.

  PMID: 28173859 BACKGROUND

• Mesquita A, Costa R, Dikmen-Yildiz P, Faria S, Silvestrini G, Mateus V, Vousoura E, Wilson CA, Felice E, Ajaz E, Hadjigeorgiou E, Hancheva C, Contreras-Garcia Y, Dominguez-Salas S, Motrico E, Soares I, Ayers S. Changes to women's childbirth plans during the COVID-19 pandemic and posttraumatic stress symptoms: a cross-national study. Arch Womens Ment Health. 2024 Jun;27(3):393-403. doi: 10.1007/s00737-023-01403-3. Epub 2023 Dec 16.

  PMID: 38102527 DERIVED

• Mesquita A, Costa R, Bina R, Cadarso-Suarez C, Gude F, Diaz-Louzao C, Dikmen-Yildiz P, Osorio A, Mateus V, Dominguez-Salas S, Vousoura E, Levy D, Alfayumi-Zeadna S, Wilson CA, Contreras-Garcia Y, Carrasco-Portino M, Saldivia S, Christoforou A, Hadjigeorgiou E, Felice E, Buhagiar R, Hancheva C, Ajaz E, Uka A, Motrico E. A cross-country study on the impact of governmental responses to the COVID-19 pandemic on perinatal mental health. Sci Rep. 2023 Feb 16;13(1):2805. doi: 10.1038/s41598-023-29300-w.

  PMID: 36797263 DERIVED

• Motrico E, Galan-Luque T, Rodriguez-Dominguez C, Gomez-Gomez I, Dominguez-Salas S. Factors Associated with Post-Traumatic Stress Symptoms in Pregnant and Postpartum Women. J Womens Health (Larchmt). 2023 May;32(5):583-591. doi: 10.1089/jwh.2022.0400. Epub 2023 Feb 14.

  PMID: 36787455 DERIVED

• Wilson CA, Gomez-Gomez I, Parsons J, Costa R, Mesquita A, Vousoura E, Contreras-Garcia Y, Levy D, Mateus V, Christoforou A, Felice E, Dikmen-Yildiz P, Dominguez-Salas S, Motrico E. The Mental Health of Women with Gestational Diabetes During the COVID-19 Pandemic: An International Cross-Sectional Survey. J Womens Health (Larchmt). 2022 Sep;31(9):1232-1240. doi: 10.1089/jwh.2021.0584. Epub 2022 Jul 19.

  PMID: 35856836 DERIVED

• Gomez-Baya D, Gomez-Gomez I, Dominguez-Salas S, Rodriguez-Dominguez C, Motrico E. The influence of lifestyles to cope with stress over mental health in pregnant and postpartum women during the COVID-19 pandemic. Curr Psychol. 2022 Jun 15:1-20. doi: 10.1007/s12144-022-03287-5. Online ahead of print.

  PMID: 35729900 DERIVED

• Motrico E, Bina R, Dominguez-Salas S, Mateus V, Contreras-Garcia Y, Carrasco-Portino M, Ajaz E, Apter G, Christoforou A, Dikmen-Yildiz P, Felice E, Hancheva C, Vousoura E, Wilson CA, Buhagiar R, Cadarso-Suarez C, Costa R, Devouche E, Ganho-Avila A, Gomez-Baya D, Gude F, Hadjigeorgiou E, Levy D, Osorio A, Rodriguez MF, Saldivia S, Gonzalez MF, Mattioli M, Mesquita A; Riseup-PPD-COVID-19 Group. Impact of the Covid-19 pandemic on perinatal mental health (Riseup-PPD-COVID-19): protocol for an international prospective cohort study. BMC Public Health. 2021 Feb 17;21(1):368. doi: 10.1186/s12889-021-10330-w.

  PMID: 33596889 DERIVED

Related Links

• Website of the project

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ana Mesquita, PhD

  University of Minho

  PRINCIPAL INVESTIGATOR

• Emma Motrico, PhD

  Universidad Loyola Andalucia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 20, 2020
• Study Start: June 15, 2020
• Primary Completion: November 1, 2020
• Study Completion: February 28, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AL (1); IL (1); GR (1); BR (1); FR (1); CL (1); PT (1); ES (1); TU (1); GB (1); BU (1); CY (1); MA (1)