Quality of Care During Childbirth Clinical Trial
— IMAgiNE-EUROOfficial 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
| Verified date | April 2021 |
| Source | WHO Collaborating Centre for Maternal and Child Health, Trieste |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Enrolling by invitation |
| Enrollment | 10000 |
| Est. completion date | September 2, 2022 |
| Est. primary completion date | March 15, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Burlo Garofolo | Trieste | Friuli Venezia Giulia Region |
| Lead Sponsor | Collaborator |
|---|---|
| WHO Collaborating Centre for Maternal and Child Health, Trieste | Administraçao Regional de Saude do Algarve - ACES Central - URAP - Albufeira, Associação Portuguesa pelos Direitos da Mulher na Gravidez e Parto, BLL-Beruffsverband vun den Laktationsberoderinnen zu Lëtzebuerg asbl, Centar za mame, Childbirth with Dignity Foundation, INED - Institut National d'Etudes Démographiques, Instituto de Saude Publica da Universidade do Porto, IRCCS Burlo Garofolo, Medical Anthropology Research Center (MARC, URV), National Institute of Public Health, Slovenia, NGO Babysteps, Riga Stradins University, Roda - Parents in Action, SAMAS Association, School of Public Health, Bielefeld University, The Sahlgrenska Academy at University of Gothenburg, UiT The Arctic University of Norway, Universidade Europeia, Lisbon, University of Exeter |
Italy,
Lazzerini M, Mariani I, Semenzato C, Valente EP. Association between maternal satisfaction and other indicators of quality of care at childbirth: a cross-sectional study based on the WHO standards. BMJ Open. 2020 Sep 14;10(9):e037063. doi: 10.1136/bmjopen-2020-037063. — View Citation
Lazzerini M, Semenzato C, Kaur J, Covi B, Argentini G. Women's suggestions on how to improve the quality of maternal and newborn hospital care: a qualitative study in Italy using the WHO standards as framework for the analysis. BMC Pregnancy Childbirth. 2020 Apr 6;20(1):200. doi: 10.1186/s12884-020-02893-0. — View Citation
Lazzerini M, Valente EP, Covi B, Semenzato C, Ciuch M. Use of WHO standards to improve quality of maternal and newborn hospital care: a study collecting both mothers' and staff perspective in a tertiary care hospital in Italy. BMJ Open Qual. 2019 Feb 13;8(1):e000525. doi: 10.1136/bmjoq-2018-000525. eCollection 2019. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of Maternal and Newborn Care Index - mean | variable from 0 to 100 points | March 2020 to March 2021 | |
| Secondary | Quality of Maternal and Newborn Care Index - total value | variable from 0 to 400 points | March 2020 to March 2021 | |
| Secondary | Index of Quality of Maternal and Newborn Care - value by domains | 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) |
March 2020 to March 2021 | |
| Secondary | Frequency of specific indicators/quality measure | Caesarean section rate Episiotomy rate Availability of specific resources |
March 2020 to March 2021 |