Quality of Care During ChildbirthIMAgiNE-EURONCT04847336
Improving MAternal Newborn carE In the in the WHO European Region During COVID-19 Pandemic
An observational study of Quality of Care During Childbirth, run by WHO Collaborating Centre for Maternal and Child Health, Trieste at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Care During Childbirth
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2020to 2 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data will be collected among mothers and among health workers providing care to mothers or infants.
Who may be able to join
- Women of any age who gave births in hospitals, from 1 march 2020
- Health workers directly involved in assistance at childbirth (pregnancy, childbirth and peripartum) at hospital level, from 1 march 2020
Who cannot join
- For women: refusal to participate; home births
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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:
- 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
- Conditions
- Quality of Care During Childbirth
- Being tested
- No intervention is planned
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is plannedOther
No intervention is planned
| Study group | Role | What they receive |
|---|---|---|
| Women | Women of any age who gave births in hospitals from WHO European Region, from 1 march 2020 Receives: Other: 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 Receives: Other: No intervention is planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Maternal and Newborn Care Index - mean
variable from 0 to 100 points
Measured: March 2020 to March 2021
Secondary outcomes (3)
Quality of Maternal and Newborn Care Index - total value
variable from 0 to 400 points
Measured: 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)
Measured: March 2020 to March 2021
Frequency of specific indicators/quality measure
- Caesarean section rate
- Episiotomy rate
- Availability of specific resources
Measured: March 2020 to March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start2 Sep 2020
- Primary completion15 Mar 2021
- Study completion2 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Quality of Care During ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WHO Collaborating Centre for Maternal and Child Health, Trieste
- Sponsor type
- University, hospital or other
- 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), Göteborg University, University of Exeter
- Responsible party
- Principal investigator, Marzia Lazzerini, WHO Collaborating Centre for Maternal and Child Health, Trieste
- Investigators
- Marzia Lazzerini, PhD Dr, Principal investigator, WHO Collaborating Center for Maternal and Child Health - IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847336
- Sponsor's protocol ID
- IRB-BURLO 05/2020
- Acronym
- IMAgiNE-EURO
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30997420Lazzerini 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.
PubMed 32928854Lazzerini 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.
PubMed 32252686Artzi-Medvedik R, Hadjigeorgiou E, Kolokotroni O, Middleton N, Valente EP, Lazzerini M, Mariani I, Azulay Chertok IR; IMAgiNE EURO Study Group. Maternity Care Experiences Among Birthing Women in Two European-Region Countries During the COVID-19 Pandemic: A Qualitative Study. Int J Nurs Pract. 2026 Apr;32(2):e70129. doi: 10.1111/ijn.70129.
PubMed 41841158Galle A, Berghman H, D'Hauwers S, Vaerewijck N, Valente EP, Mariani I, Bomben A, Delle Vedove S, Lazzerini M; IMAgiNE EURO Study Group. Quality of care at childbirth during the COVID-19 pandemic in Belgium: a cross-sectional study based on WHO standards. BMJ Open. 2024 Dec 27;14(12):e086937. doi: 10.1136/bmjopen-2024-086937.
PubMed 39732493Zaigham M, Linden K, Elden H, Delle Vedove S, Mariani I, Kongslien S, Drandic D, Pumpure E, Drglin Z, Costa R, Sarantaki A, de Labrusse C, Miani C, Otelea MR, Liepinaitiene A, Baranowska B, Rozee V, Valente EP, Vik ES, Kurbanovic M, Jakovicka D, Bohinec A, Dias H, Metallinou D, Mueller AN, Batram-Zantvoort S, Handra CM, Mizgaitiene M, Tataj-Puzyna U, Bomben A, Nedberg IH, Voitehovica E, Pinto TM, Lykeridou A, Grylka-Baeschlin S, Jazdauskiene S, Szlendak B, Sacks E, Lazzerini M; IMAgiNE EURO Study group. Trends in the quality of maternal and neonatal care in Sweden and Norway as compared to 12 WHO European countries: A cross-sectional survey investigating maternal perspectives during the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2024 Dec;103(12):2485-2498. doi: 10.1111/aogs.14994. Epub 2024 Oct 21.
PubMed 39431577Grylka-Baeschlin S, Gemperle M, Mariani I, Abderhalden-Zellweger A, Miani C, Zenzmaier C, Mueller AN, Batram-Zantvoort S, Koenig-Bachmann M, De Labrusse C, Arendt M, Vedove SD, Pfund A, Simon I, Valente EP, Lazzerini M; IMAgiNE Euro Study Group. Women 's perception on the quality of maternal and newborn care during the COVID-19 pandemic in German-speaking countries: Findings from the IMAgiNE EURO project comparing data from Germany, Switzerland and Austria. Midwifery. 2025 Jan;140:104209. doi: 10.1016/j.midw.2024.104209. Epub 2024 Oct 11.
PubMed 39423767Valente EP, Mariani I, Bomben A, Morano S, Gemperle M, Otelea MR, Miani C, Elden H, Sarantaki A, Costa R, Baranowska B, Konig-Bachmann M, Kongslien S, Drandic D, Rozee V, Nespoli A, Abderhalden-Zellweger A, Nanu I, Batram-Zantvoort S, Linden K, Metallinou D, Dias H, Tataj-Puzyna U, D'Costa E, Nedberg IH, Kurbanovic M, de La Rochebrochard E, Fumagalli S, Grylka-Baeschlin S, Handra CM, Zaigham M, Orovou E, Barata C, Szlendak B, Zenzmaier C, Vik ES, Liepinaitiene A, Drglin Z, Arendt M, Sacks E, Lazzerini M; Improving MAternal Newborn carE in the EURO Region (IMAgiNE EURO) Study Group. Health workers' perspectives on the quality of maternal and newborn health care around the time of childbirth: Results of the Improving MAternal Newborn carE in the EURO Region (IMAgiNE EURO) project in 12 countries of the World Health Organization European Region. J Glob Health. 2024 Sep 6;14:04164. doi: 10.7189/jogh.14.04164.
PubMed 39238363Artzi-Medvedik R, Mariani I, Valente EP, Lazzerini M, Chertok IA. Factors associated with exclusive breastfeeding in Israel during the COVID-19 pandemic: a subset of the IMAgiNE EURO cross-sectional study. Int Breastfeed J. 2023 Jun 9;18(1):30. doi: 10.1186/s13006-023-00568-y.
PubMed 37296409Geremia S, Valente EP, Mariani I, Dalena P, Lazzerini M. Women's suggestions on how to improve the quality of maternal and newborn care during the COVID-19 pandemic in Italy: A co-occurrence network analysis. J Glob Health. 2023 May 5;13:06013. doi: 10.7189/jogh.13.06013.
PubMed 37144478Pumpure E, Jakovicka D, Mariani I, Vaska A, Covi B, Valente EP, Jansone-Santare G, Knoka AR, Vilcane KP, Rezeberga D, Lazzerini M; IMAgiNE EURO study group. Women's perspectives on the quality of maternal and newborn care in childbirth during the COVID-19 pandemic in Latvia: Results from the IMAgiNE EURO study on 40 WHO standards-based quality measures. Int J Gynaecol Obstet. 2022 Dec;159 Suppl 1(Suppl 1):97-112. doi: 10.1002/ijgo.14461.
PubMed 36530013Otelea MR, Simionescu AA, Mariani I, Valente EP, Nanu MI, Nanu I, Handra CM, Covi B, Lazzerini M; IMAgiNE EURO Study Group. Women's assessment of the quality of hospital-based perinatal care by mode of birth in Romania during the COVID-19 pandemic: Results from the IMAgiNE EURO study. Int J Gynaecol Obstet. 2022 Dec;159 Suppl 1(Suppl 1):126-136. doi: 10.1002/ijgo.14482.
PubMed 36530009Lazzerini M, Valente EP, Covi B, Rozee V, Costa R, Otelea MR, Abderhalden-Zellweger A, Wegrzynowska M, Linden K, Arendt M, Brigidi S, Miani C, Pumpure E, Radetic J, Drandic D, Cerimagic A, Nedberg IH, Liepinaitiene A, Rodrigues C, de Labrusse C, Baranowska B, Zaigham M, Castaneda LM, Batram-Zantvoort S, Jakovicka D, Ruzicic J, Juciute S, Santos T, Gemperle M, Tataj-Puzyna U, Elden H, Mizgaitiene M, Lincetto O, Sacks E, Mariani I; IMAgiNE EURO study group. Rates of instrumental vaginal birth and cesarean and quality of maternal and newborn health care in private versus public facilities: Results of the IMAgiNE EURO study in 16 countries. Int J Gynaecol Obstet. 2022 Dec;159 Suppl 1(Suppl 1):22-38. doi: 10.1002/ijgo.14458.
PubMed 36530007Drandic D, Drglin Z, Mihevc Ponikvar B, Bohinec A, Cerimagic A, Radetic J, Ruzicic J, Kurbanovic M, Covi B, Valente EP, Mariani I, Lazzerini M; IMAgiNE EURO study group. Women's perspectives on the quality of hospital maternal and newborn care around the time of childbirth during the COVID-19 pandemic: Results from the IMAgiNE EURO study in Slovenia, Croatia, Serbia, and Bosnia-Herzegovina. Int J Gynaecol Obstet. 2022 Dec;159 Suppl 1(Suppl 1):54-69. doi: 10.1002/ijgo.14457.
PubMed 36530003Chertok IA, Artzi-Medvedik R, Arendt M, Sacks E, Otelea MR, Rodrigues C, Costa R, Linden K, Zaigham M, Elden H, Drandic D, Grylka-Baeschlin S, Miani C, Valente EP, Covi B, Lazzerini M, Mariani I. Factors associated with exclusive breastfeeding at discharge during the COVID-19 pandemic in 17 WHO European Region countries. Int Breastfeed J. 2022 Dec 2;17(1):83. doi: 10.1186/s13006-022-00517-1.
PubMed 36461061
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04847336
- Acronym / sponsor ID
- IMAgiNE-EURO / IRB-BURLO 05/2020
- Conditions
- Quality of Care During Childbirth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- WHO Collaborating Centre for Maternal and Child Health, TriesteUniversity, hospital or other
- 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), Göteborg University, University of Exeter
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 2 Sep 2022 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | – | Other: No intervention is plannedWomen of any age who gave births in hospitals from WHO European Region, from 1 march 2020 |
| Health workers | – | Other: No intervention is plannedHealth workers directly involved in assistance at childbirth (pregnancy, childbirth and peripartum) at hospital level in WHO European Region, from 1 march 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected among mothers and among health workers providing care to mothers or infants.
Key inclusion criteria (2 listed)
- Women of any age who gave births in hospitals, from 1 march 2020
- Health workers directly involved in assistance at childbirth (pregnancy, childbirth and peripartum) at hospital level, from 1 march 2020
Key exclusion criteria (2 listed)
- For women: refusal to participate; home births
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is plannedNo intervention is planned | Other | Health workers, Women |
Primary outcome
Quality of Maternal and Newborn Care Index - mean
Time frame: March 2020 to March 2021
variable from 0 to 100 points
3 secondary outcomes
Quality of Maternal and Newborn Care Index - total value
Time frame: March 2020 to March 2021
Index of Quality of Maternal and Newborn Care - value by domains
Time frame: March 2020 to March 2021
Frequency of specific indicators/quality measure
Time frame: March 2020 to March 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Background: PubMed 30997420Lazzerini 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.
- Background: PubMed 32928854Lazzerini 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.
- Background: PubMed 32252686Lazzerini 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.
- Derived from this study: PubMed 41841158Artzi-Medvedik R, Hadjigeorgiou E, Kolokotroni O, Middleton N, Valente EP, Lazzerini M, Mariani I, Azulay Chertok IR; IMAgiNE EURO Study Group. Maternity Care Experiences Among Birthing Women in Two European-Region Countries During the COVID-19 Pandemic: A Qualitative Study. Int J Nurs Pract. 2026 Apr;32(2):e70129. doi: 10.1111/ijn.70129.
- Derived from this study: PubMed 39732493Galle A, Berghman H, D'Hauwers S, Vaerewijck N, Valente EP, Mariani I, Bomben A, Delle Vedove S, Lazzerini M; IMAgiNE EURO Study Group. Quality of care at childbirth during the COVID-19 pandemic in Belgium: a cross-sectional study based on WHO standards. BMJ Open. 2024 Dec 27;14(12):e086937. doi: 10.1136/bmjopen-2024-086937.
- Derived from this study: PubMed 39431577Zaigham M, Linden K, Elden H, Delle Vedove S, Mariani I, Kongslien S, Drandic D, Pumpure E, Drglin Z, Costa R, Sarantaki A, de Labrusse C, Miani C, Otelea MR, Liepinaitiene A, Baranowska B, Rozee V, Valente EP, Vik ES, Kurbanovic M, Jakovicka D, Bohinec A, Dias H, Metallinou D, Mueller AN, Batram-Zantvoort S, Handra CM, Mizgaitiene M, Tataj-Puzyna U, Bomben A, Nedberg IH, Voitehovica E, Pinto TM, Lykeridou A, Grylka-Baeschlin S, Jazdauskiene S, Szlendak B, Sacks E, Lazzerini M; IMAgiNE EURO Study group. Trends in the quality of maternal and neonatal care in Sweden and Norway as compared to 12 WHO European countries: A cross-sectional survey investigating maternal perspectives during the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2024 Dec;103(12):2485-2498. doi: 10.1111/aogs.14994. Epub 2024 Oct 21.
- Derived from this study: PubMed 39423767Grylka-Baeschlin S, Gemperle M, Mariani I, Abderhalden-Zellweger A, Miani C, Zenzmaier C, Mueller AN, Batram-Zantvoort S, Koenig-Bachmann M, De Labrusse C, Arendt M, Vedove SD, Pfund A, Simon I, Valente EP, Lazzerini M; IMAgiNE Euro Study Group. Women 's perception on the quality of maternal and newborn care during the COVID-19 pandemic in German-speaking countries: Findings from the IMAgiNE EURO project comparing data from Germany, Switzerland and Austria. Midwifery. 2025 Jan;140:104209. doi: 10.1016/j.midw.2024.104209. Epub 2024 Oct 11.
- Derived from this study: PubMed 39238363Valente EP, Mariani I, Bomben A, Morano S, Gemperle M, Otelea MR, Miani C, Elden H, Sarantaki A, Costa R, Baranowska B, Konig-Bachmann M, Kongslien S, Drandic D, Rozee V, Nespoli A, Abderhalden-Zellweger A, Nanu I, Batram-Zantvoort S, Linden K, Metallinou D, Dias H, Tataj-Puzyna U, D'Costa E, Nedberg IH, Kurbanovic M, de La Rochebrochard E, Fumagalli S, Grylka-Baeschlin S, Handra CM, Zaigham M, Orovou E, Barata C, Szlendak B, Zenzmaier C, Vik ES, Liepinaitiene A, Drglin Z, Arendt M, Sacks E, Lazzerini M; Improving MAternal Newborn carE in the EURO Region (IMAgiNE EURO) Study Group. Health workers' perspectives on the quality of maternal and newborn health care around the time of childbirth: Results of the Improving MAternal Newborn carE in the EURO Region (IMAgiNE EURO) project in 12 countries of the World Health Organization European Region. J Glob Health. 2024 Sep 6;14:04164. doi: 10.7189/jogh.14.04164.
- Derived from this study: PubMed 37296409Artzi-Medvedik R, Mariani I, Valente EP, Lazzerini M, Chertok IA. Factors associated with exclusive breastfeeding in Israel during the COVID-19 pandemic: a subset of the IMAgiNE EURO cross-sectional study. Int Breastfeed J. 2023 Jun 9;18(1):30. doi: 10.1186/s13006-023-00568-y.
- Derived from this study: PubMed 37144478Geremia S, Valente EP, Mariani I, Dalena P, Lazzerini M. Women's suggestions on how to improve the quality of maternal and newborn care during the COVID-19 pandemic in Italy: A co-occurrence network analysis. J Glob Health. 2023 May 5;13:06013. doi: 10.7189/jogh.13.06013.
- Derived from this study: PubMed 36530013Pumpure E, Jakovicka D, Mariani I, Vaska A, Covi B, Valente EP, Jansone-Santare G, Knoka AR, Vilcane KP, Rezeberga D, Lazzerini M; IMAgiNE EURO study group. Women's perspectives on the quality of maternal and newborn care in childbirth during the COVID-19 pandemic in Latvia: Results from the IMAgiNE EURO study on 40 WHO standards-based quality measures. Int J Gynaecol Obstet. 2022 Dec;159 Suppl 1(Suppl 1):97-112. doi: 10.1002/ijgo.14461.
- Derived from this study: PubMed 36530009Otelea MR, Simionescu AA, Mariani I, Valente EP, Nanu MI, Nanu I, Handra CM, Covi B, Lazzerini M; IMAgiNE EURO Study Group. Women's assessment of the quality of hospital-based perinatal care by mode of birth in Romania during the COVID-19 pandemic: Results from the IMAgiNE EURO study. Int J Gynaecol Obstet. 2022 Dec;159 Suppl 1(Suppl 1):126-136. doi: 10.1002/ijgo.14482.
- Webpage were survey links for women (in more than 20 languages) and health workers (in more than 10 languages)are available.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzia Lazzerini, PhD Dr principal investigator
WHO Collaborating Center for Maternal and Child Health - IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Care During Childbirth, run by WHO Collaborating Centre for Maternal and Child Health, Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Maternal and Newborn Care Index - mean (time frame: March 2020 to March 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847336, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.