IMAgiNE-EURO: Improving MAternal Newborn carE In the in the WHO European Region During COVID-19 Pandemic

Sponsor
WHO Collaborating Centre for Maternal and Child Health, Trieste (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04847336
Collaborator
IRCCS Burlo Garofolo (Other), NGO Babysteps (Other), Roda - Parents in Action (Other), INED - Institut National d'Etudes Démographiques (Other), School of Public Health, Bielefeld University (Other), Riga Stradins University (Other), BLL-Beruffsverband vun den Laktationsberoderinnen zu Lëtzebuerg asbl (Other), UiT The Arctic University of Norway (Other), Childbirth with Dignity Foundation (Other), Instituto de Saude Publica da Universidade do Porto (Other), Administraçao Regional de Saude do Algarve - ACES Central - URAP - Albufeira (Other), Associação Portuguesa pelos Direitos da Mulher na Gravidez e Parto (Other), Universidade Europeia, Lisbon (Other), SAMAS Association (Other), Centar za mame (Other), National Institute of Public Health, Slovenia (Other), Medical Anthropology Research Center (MARC, URV) (Other), The Sahlgrenska Academy at University of Gothenburg (Other), University of Exeter (Other)
10,000
1
24
417

Study Details

Study Description

Brief Summary

BACKGROUND COVID-19 response is heavily impacting the availability of essential health services, especially services for pregnant women and newborns that cannot be delayed or rapidly reorganized in other settings. In the current pandemic, due to multiple factors access to high quality and timely maternal and newborn (MN) health care is threatened. Major concerns have also been raised with respect to maternal rights and on disruption of essential practices and increased medicalization of care, despite existing WHO guidance.

Based on preliminary reports heterogeneities in practices is expected within the WHO European Region, with major inequities (eg women experiencing disruption of essential MC health services only in selected countries or areas within the countries, while having access to adequate care in others).

With IMAgiNE EURO we aim at conducting a survey to explore the health service preparedness, quality and resilience, with a specific focus on health services around the time of childbirth, in the WHO European Region during COVID-19 pandemic, and to make available data, which, in collaboration with WHO and other partners, can contribute in improving the quality of MN health care.

HYPHOTESIS AND SIGNIFICANCE

  • This project has been developed in coordination with WHO Regional Office for Europe (EURO) and other partners, and ultimately aims at making available and disseminate data that can help improving the quality of MN health services in the Region. Collecting data on the quality of essential MN health services across different countries within the WHO European Region will help addressing specific gaps and planning coordinate response to improve quality of MN care and improve MN health outcomes.

  • The project will also offer the opportunity to develop tools and methods to monitor the quality of MN health care across different countries and settings.

  • The project will establish and consolidate a research network

Primary objective:
  1. Record, analyse, and describe data on MN health service preparedness, quality and resilience - with a specific focus around the time of childbirth as measured both from health workers and women perspectives- across different countries within the WHO European Region, during COVID-19 pandemic.

Secondary objectives: 2.Develop tools and methods to measure, through rapid online surveys, the quality of MN health care across different countries and settings 3.Establish and consolidate a research network

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention is planned

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
IMAGINE EURO (Improving MAternal Newborn carE In the EURO Region): Maternal and Newborn Health Service Preparedness, Quality and Resilience, Among Countries of the WHO European Region, During the COVID-19 Pandemic
Actual Study Start Date :
Sep 2, 2020
Actual Primary Completion Date :
Mar 15, 2021
Anticipated Study Completion Date :
Sep 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Women

Women of any age who gave births in hospitals from WHO European Region, from 1 march 2020

Other: No intervention is planned
No intervention is planned

Health workers

Health workers directly involved in assistance at childbirth (pregnancy, childbirth and peripartum) at hospital level in WHO European Region, from 1 march 2020

Other: No intervention is planned
No intervention is planned

Outcome Measures

Primary Outcome Measures

  1. Quality of Maternal and Newborn Care Index - mean [March 2020 to March 2021]

    variable from 0 to 100 points

Secondary Outcome Measures

  1. Quality of Maternal and Newborn Care Index - total value [March 2020 to March 2021]

    variable from 0 to 400 points

  2. Index of Quality of Maternal and Newborn Care - value by domains [March 2020 to March 2021]

    Index for availability of human and physical resources (variable from 0 to 100 points) Index for provision of care (variable from 0 to 100 points) Index for experience of care (variable from 0 to 100 points) Index for COVID-19 related care (variable from 0 to 100 points)

  3. Frequency of specific indicators/quality measure [March 2020 to March 2021]

    Caesarean section rate Episiotomy rate Availability of specific resources

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Women of any age who gave births in hospitals, from 1 march 2020

  2. Health workers directly involved in assistance at childbirth (pregnancy, childbirth and peripartum) at hospital level, from 1 march 2020

Exclusion Criteria:
  1. For women: refusal to participate; home births

  2. For health workers: personnel not directly involved in the routine care t childbirth (es physiotherapist, philologist), refusal to participate; absence from work for more than 2 months out of the 4 months immediately before the survey; less than 1 year of experience

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Burlo Garofolo Trieste Friuli Venezia Giulia Region Italy 34137

Sponsors and Collaborators

  • WHO Collaborating Centre for Maternal and Child Health, Trieste
  • IRCCS Burlo Garofolo
  • NGO Babysteps
  • Roda - Parents in Action
  • INED - Institut National d'Etudes Démographiques
  • School of Public Health, Bielefeld University
  • Riga Stradins University
  • BLL-Beruffsverband vun den Laktationsberoderinnen zu Lëtzebuerg asbl
  • UiT The Arctic University of Norway
  • Childbirth with Dignity Foundation
  • Instituto de Saude Publica da Universidade do Porto
  • Administraçao Regional de Saude do Algarve - ACES Central - URAP - Albufeira
  • Associação Portuguesa pelos Direitos da Mulher na Gravidez e Parto
  • Universidade Europeia, Lisbon
  • SAMAS Association
  • Centar za mame
  • National Institute of Public Health, Slovenia
  • Medical Anthropology Research Center (MARC, URV)
  • The Sahlgrenska Academy at University of Gothenburg
  • University of Exeter

Investigators

  • Principal Investigator: Marzia Lazzerini, PhD Dr, WHO Collaborating Center for Maternal and Child Health - IRCCS Burlo Garofolo

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Marzia Lazzerini, paediatrician, DTMH, Msc, PhD Director SS WHO Collaborating Center IRCCS Burlo Trieste Italy, WHO Collaborating Centre for Maternal and Child Health, Trieste
ClinicalTrials.gov Identifier:
NCT04847336
Other Study ID Numbers:
  • IRB-BURLO 05/2020
First Posted:
Apr 19, 2021
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2021