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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04847336
Recruitment Status : Enrolling by invitation
First Posted : April 19, 2021
Last Update Posted : April 21, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Marzia Lazzerini, WHO Collaborating Centre for Maternal and Child Health, Trieste

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
Quality of Care During Childbirth Other: No intervention is planned

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Study Type : Observational
Estimated 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 : September 2, 2020
Actual Primary Completion Date : March 15, 2021
Estimated Study Completion Date : September 2, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Quality of Maternal and Newborn Care Index - mean [ Time Frame: March 2020 to March 2021 ]
    variable from 0 to 100 points


Secondary Outcome Measures :
  1. Quality of Maternal and Newborn Care Index - total value [ Time Frame: March 2020 to March 2021 ]
    variable from 0 to 400 points

  2. Index of Quality of Maternal and Newborn Care - value by domains [ Time Frame: 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 [ Time Frame: March 2020 to March 2021 ]
    • Caesarean section rate
    • Episiotomy rate
    • Availability of specific resources



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Data will be collected among mothers and among health workers providing care to mothers or infants.
Criteria

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

Information from the National Library of Medicine

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): NCT04847336


Locations
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Italy
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
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Principal Investigator: Marzia Lazzerini, PhD Dr WHO Collaborating Center for Maternal and Child Health - IRCCS Burlo Garofolo
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: April 19, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases