Clinical trial NCT04847336: Improving MAternal Newborn carE In the in the WHO European Region During COVID-19 Pandemic
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Care During Childbirth
Lead sponsor: WHO Collaborating Centre for Maternal and Child Health, Trieste
Sponsor class: OTHER
Collaborators: name: IRCCS Burlo Garofolo
name: NGO Babysteps
name: Roda - Parents in Action
name: INED - Institut National d'Etudes Démographiques
name: School of Public Health, Bielefeld University
name: Riga Stradins University
name: BLL-Beruffsverband vun den Laktationsberoderinnen zu Lëtzebuerg asbl
name: UiT The Arctic University of Norway
name: Childbirth with Dignity Foundation
name: Instituto de Saude Publica da Universidade do Porto
name: Administraçao Regional de Saude do Algarve - ACES Central - URAP - Albufeira
name: Associação Portuguesa pelos Direitos da Mulher na Gravidez e Parto
name: Universidade Europeia, Lisbon
name: SAMAS Association
name: Centar za mame
name: National Institute of Public Health, Slovenia
name: Medical Anthropology Research Center (MARC, URV)
name: Göteborg University
name: University of Exeter
First posted: 2021-04-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected among mothers and among health workers providing care to mothers or infants.

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


Eligibility 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

Primary outcomes:
measure: Quality of Maternal and Newborn Care Index - mean
timeFrame: March 2020 to March 2021
Secondary outcomes:
measure: Quality of Maternal and Newborn Care Index - total value
timeFrame: March 2020 to March 2021
measure: Index of Quality of Maternal and Newborn Care - value by domains
timeFrame: March 2020 to March 2021
measure: Frequency of specific indicators/quality measure
timeFrame: March 2020 to March 2021
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
state: Friuli Venezia Giulia Region
Study officials:
affiliation: WHO Collaborating Center for Maternal and Child Health - IRCCS Burlo Garofolo
name: Marzia Lazzerini, PhD Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: Valente EP, Covi B, Mariani I, Morano S, Otalea M, Nanu I, Nanu MI, Elden H, Linden K, Zaigham M, Vik ES, Kongslien S, Nedberg I, Costa R, Rodrigues C, Dias H, Drandic D, Kurbanovic M, Sacks E, Muzigaba M, Lincetto O, Lazzerini M; IMAgiNE EURO Study Group. WHO Standards-based questionnaire to measure health workers' perspective on the quality of care around the time of childbirth in the WHO European region: development and mixed-methods validation in six countries. BMJ Open. 2022 Apr 8;12(4):e056753. doi: 10.1136/bmjopen-2021-056753.
citation: Lazzerini M, Covi B, Mariani I, Drglin Z, Arendt M, Nedberg IH, Elden H, Costa R, Drandic D, Radetic J, Otelea MR, Miani C, Brigidi S, Rozee V, Ponikvar BM, Tasch B, Kongslien S, Linden K, Barata C, Kurbanovic M, Ruzicic J, Batram-Zantvoort S, Castaneda LM, Rochebrochard E, Bohinec A, Vik ES, Zaigham M, Santos T, Wandschneider L, Viver AC, Cerimagic A, Sacks E, Valente EP; IMAgiNE EURO study group. Quality of facility-based maternal and newborn care around the time of childbirth during the COVID-19 pandemic: online survey investigating maternal perspectives in 12 countries of the WHO European Region. Lancet Reg Health Eur. 2022 Feb;13:100268. doi: 10.1016/j.lanepe.2021.100268. Epub 2021 Dec 24.