NCT04779775

Brief Summary

The COVID-19 pandemic has caused changes in health care during pregnancy, childbirth and postpartum. Although adverse effects of COVID-19 on perinatal mental health have been documented, changes in the perinatal mental health care provided to women and their families are yet to be established. As a Task Force in Perinatal mental health and COVID-19 pandemic within RISEUP-PPD COST Action, we aim: (i) to identify policies, guidelines and protocols from different European countries concerning the provision of perinatal mental health care in face of COVID-19, and (ii) to select the best practices to alleviate the negative impact of COVID-19 on perinatal mental health. The survey will be conducted among experts in perinatal mental health who are members of the COST Action RISEUP-PPD and COST Action Devotion in 36 European countries. The experts will fill in the online survey designed for this study that includes a series of open-ended questions, checklists, and response ratings on a 7-point scale. The topic areas cover seven domains of interest: 1) mental health policies, guidelines, protocols, and documents; 2) mental health care practices; 3) best practices; 4) barriers; 5) resources; 6) benefits; and 7) short- and long-term expectations. Data analysis will be mainly a qualitative analysis of the experts' professional views and opinions about the policies, guidelines, protocols, and documents regarding perinatal mental health changes in their country. Additionally, a basic quantitative descriptive analysis will be conducted.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

February 10, 2021

Last Update Submit

April 28, 2021

Conditions

Keywords

perinatal mental health policiesguidelinesprotocolsperinatal care practicesbest practices during COVID-19

Outcome Measures

Primary Outcomes (2)

  • Changes in perinatal best practices

    Questionnaire on changes in perinatal mental health care practices during the COVID-19 Pandemic

    March 2020- June 2021

  • Changes in perinatal mental health protocols

    Questionnaire on changes in perinatal mental health care practices during the COVID-19 Pandemic

    March 2020- June 2021

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Experts in perinatal mental health who are the members of the COST Action RISEUP-PPD and the COST Action Devotion

You may qualify if:

  • experts working in perinatal care services within the COST actions RISEUP-PPD and Devotion

You may not qualify if:

  • COST members working in perinatal mental health less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.

    PMID: 32112714BACKGROUND
  • Chen D, Yang H, Cao Y, Cheng W, Duan T, Fan C, Fan S, Feng L, Gao Y, He F, He J, Hu Y, Jiang Y, Li Y, Li J, Li X, Li X, Lin K, Liu C, Liu J, Liu X, Pan X, Pang Q, Pu M, Qi H, Shi C, Sun Y, Sun J, Wang X, Wang Y, Wang Z, Wang Z, Wang C, Wu S, Xin H, Yan J, Zhao Y, Zheng J, Zhou Y, Zou L, Zeng Y, Zhang Y, Guan X. Expert consensus for managing pregnant women and neonates born to mothers with suspected or confirmed novel coronavirus (COVID-19) infection. Int J Gynaecol Obstet. 2020 May;149(2):130-136. doi: 10.1002/ijgo.13146. Epub 2020 Apr 1.

    PMID: 32196655BACKGROUND
  • Ciotti M, Ciccozzi M, Terrinoni A, Jiang WC, Wang CB, Bernardini S. The COVID-19 pandemic. Crit Rev Clin Lab Sci. 2020 Sep;57(6):365-388. doi: 10.1080/10408363.2020.1783198. Epub 2020 Jul 9.

    PMID: 32645276BACKGROUND
  • COST Action "Devotion": Perinatal Mental Health and Birth Related Trauma: Maximising Best Practices and Optimal Outcomes. (2020). COVID in different countries - group discussion.

    BACKGROUND
  • Davenport MH, Meyer S, Meah VL, Strynadka MC, Khurana R. Moms Are Not OK: COVID-19 and Maternal Mental Health. Front Glob Womens Health. 2020 Jun 19;1:1. doi: 10.3389/fgwh.2020.00001. eCollection 2020.

    PMID: 34816146BACKGROUND
  • European Commission. (2013). Mental health systems in the European Union member states, status of mental health in populations and benefits to be expected from investments into mental health main report. (July), 1-574.

    BACKGROUND
  • Fonseca A, Ganho-Avila A, Lambregtse-van den Berg M, Lupattelli A, Rodriguez-Munoz MF, Ferreira P, Rados SN, Bina R. Emerging issues and questions on peripartum depression prevention, diagnosis and treatment: a consensus report from the cost action riseup-PPD. J Affect Disord. 2020 Sep 1;274:167-173. doi: 10.1016/j.jad.2020.05.112. Epub 2020 May 23.

    PMID: 32469800BACKGROUND
  • Motrico, E., Mateus, V., Bina, R., Felice, E., Bramante, A., Kalcev, G., ... & Mesquita, A. Good practices in perinatal mental health during the COVID-19 pandemic: a report from Task-force RISEUP-PPD COVID-19. Clínica y Salud. 2020; 31(3), 155-160.

    BACKGROUND
  • Queensland Clinical Guidelines (2020). Perinatal care of suspected or confirmed COVID-19 pregnant women. Guideline No. MN20.63-V2-R25. Queensland Health. Available from: http://www.health.qld.gov.au/qcg

    BACKGROUND
  • Saccone G, Florio A, Aiello F, Venturella R, De Angelis MC, Locci M, Bifulco G, Zullo F, Di Spiezio Sardo A. Psychological impact of coronavirus disease 2019 in pregnant women. Am J Obstet Gynecol. 2020 Aug;223(2):293-295. doi: 10.1016/j.ajog.2020.05.003. Epub 2020 May 7. No abstract available.

    PMID: 32387321BACKGROUND
  • Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.

    PMID: 32374420BACKGROUND
  • Topalidou A, Thomson G, Downe S. COVID-19 and maternal mental health: Are we getting the balance right? medRxiv. 2020; https://doi.org/10.1101/2020.03.30.20047969

    BACKGROUND
  • World Health Organization [WHO] (2020a). WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/ Accessed 16 December 2020.

    BACKGROUND
  • Thomson S, Doan T, Liu D, Schubert KO, Toh J, Boyd MA, Galletly C. Supporting the vulnerable: developing a strategic community mental health response to the COVID-19 pandemic. Australas Psychiatry. 2020 Oct;28(5):492-499. doi: 10.1177/1039856220944701. Epub 2020 Jul 30.

    PMID: 32729320BACKGROUND
  • Rados SN, Motrico E, Mesquita AM, Ganho-Avila A, Vousoura E, Lalor J. Changes in perinatal mental healthcare during the COVID-19 pandemic: a protocol for a collaborative research study between the COST actions RISEUP-PPD and DEVOTION. BMJ Open. 2022 Jul 26;12(7):e052411. doi: 10.1136/bmjopen-2021-052411.

Study Officials

  • Ana Mesquita, PhD

    University of Minho

    PRINCIPAL INVESTIGATOR
  • Emma Motrico, PhD

    University of Loyola

    PRINCIPAL INVESTIGATOR
  • Sandra Nakić Radoš, PhD

    Catholic University of Croatia

    PRINCIPAL INVESTIGATOR
  • Ana Ganho, PhD

    University of Coimbra

    PRINCIPAL INVESTIGATOR
  • Joan Lalor, PhD

    Trinity College of Dublin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2021

First Posted

March 3, 2021

Study Start

June 1, 2021

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04