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Implementation of WHO Standards for Improving Maternal and Newborn Care

Implementation of WHO Standards for Improving the Quality of Maternal-neonatal Care

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06012591
Acronym
IMAgiNE
Enrollment
9000
Registered
2023-08-25
Start date
2022-09-01
Completion date
2026-01-15
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Care

Keywords

maternal and newborn care, quality of care, quality improvement, WHO standards

Brief summary

High-quality respectful care around the time of childbirth is a fundamental aspect of human rights and, according to recent global estimates, could prevent more than 100,000 maternal deaths and 1.3 million neonatal deaths annually. Despite some maternal and newborn health indicators in high-income countries being better in comparison to low-income and middle-income countries, existing evidence shows that improvements are needed in the quality of care provided to women and newborns in every country. In 2016, the World Health Organization (WHO) developed a framework and a list of Standards for improving the quality of maternal and newborn care (QMNC). The WHO Standards define a set of 318 Quality Measures, divided into three key domains - experience of care, provision of care and availability of resources - which can be used to assess the QMNC at facility level. The ongoing project, named IMAgiNE (Improving MAternal Newborn carE), includes all maternities hospitals of the FVG Region and aimed at improving the quality of maternal and neonatal health care in the region. Quality of care is assessed using two complementary perspectives (women and health workers), with two validated questionnaires including about 100 quality measures based on the WHO Standards. It provides data on both the baseline assessment and the Quality Improvement component (progresses made).

Interventions

OTHERQuality improvement recommendations (action plans)

Developed and implemented at facility level to address key quality gaps emerging from the baseline assessment

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Before-after study

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

For women: 1\. Women who give birth at the nine maternity hospitals of the Friuli Venezia Giulia (FVG) Region, Italy For health workers 1\. All health workers directly involved in maternal/neonatal care at facility level in the FVG Region (i.e. general physicians currently working in maternal or neonatal care, midwives, nurses, neonatologists, obstetrics and gynecology doctors, and medical residents )

Exclusion criteria

For women: 1. Age \<18 years; 2. Stillbirth or neonatal death; 3. Psychiatric problems who may interfere with the telephone interview; 4. Hidden pregnancy or women whose child has been adopted or placed in foster care; 5. Refusal to participate. For health workers 1. Refusal to participate; 2. Prolonged absence with unavailability during the study period.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Maternal and Newborn Care Index evaluated by womenAt hospital discharge (assessed up to day 5)Evaluated by questionnaire
Quality of Maternal and Newborn Care Index evaluated by health professionalsAt hospital discharge (assessed up to day 5)Evaluated by questionnaire

Secondary

MeasureTime frame
Frequency of caesarean sectionAt hospital discharge (assessed up to day 5)
Frequency of episiotomyAt hospital discharge (assessed up to day 5)

Countries

Italy

Contacts

Primary ContactMarzia Lazzerini, MD
marzia.lazzerini@burlo.trieste.it+390403785555
Backup ContactEmanuelle Pessa Valente, MD
emanuelle.pessavalente@burlo.trieste.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026