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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Care During Childbirth
• Intervention / Treatment: Other: No intervention is planned

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia Region
    • Trieste, Friuli Venezia Giulia Region, Italy, 34137
      • IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Data will be collected among mothers and among health workers providing care to mothers or infants.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Maternal and Newborn Care Index - mean	variable from 0 to 100 points	March 2020 to March 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Maternal and Newborn Care Index - total value	variable from 0 to 400 points	March 2020 to March 2021
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
Frequency of specific indicators/quality measure	Caesarean section rate; Episiotomy rate; Availability of specific resources	March 2020 to March 2021

Collaborators and Investigators

• Sponsor: WHO Collaborating Centre for Maternal and Child Health, Trieste
• Collaborators: National Institute of Public Health, Slovenia; IRCCS Burlo Garofolo; University of Exeter; UiT The Arctic University of Norway; Riga Stradins University; Instituto de Saude Publica da Universidade do Porto; NGO Babysteps; Roda - Parents in Action; INED - Institut National d'Etudes Démographiques; School of Public Health, Bielefeld University; BLL-Beruffsverband vun den Laktationsberoderinnen zu Lëtzebuerg asbl; Childbirth with Dignity Foundation; 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; Medical Anthropology Research Center (MARC, URV); The Sahlgrenska Academy at University of Gothenburg
• Investigators: Principal Investigator: Marzia Lazzerini, PhD Dr, WHO Collaborating Center for Maternal and Child Health - IRCCS Burlo Garofolo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Lancet Reg Health Eur. 2022 Jul 22;19:100461.

Helpful Links

• Webpage were survey links for women (in more than 20 languages) and health workers (in more than 10 languages)are available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2020
• Primary Completion (ACTUAL): March 15, 2021
• Study Completion (ANTICIPATED): September 2, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (ACTUAL): April 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB-BURLO 05/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No