Clinical trial NCT06012591: Implementation of WHO Standards for Improving Maternal and Newborn Care
Official title: Implementation of WHO Standards for Improving the Quality of Maternal-neonatal Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Care
Keywords: maternal and newborn care
quality of care
quality improvement
WHO standards
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before-after study
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Maternal and Newborn Care Index evaluated by women
timeFrame: At hospital discharge (assessed up to day 5)
measure: Quality of Maternal and Newborn Care Index evaluated by health professionals
timeFrame: At hospital discharge (assessed up to day 5)
Secondary outcomes:
measure: Frequency of caesarean section
timeFrame: At hospital discharge (assessed up to day 5)
measure: Frequency of episiotomy
timeFrame: At hospital discharge (assessed up to day 5)
Other outcomes:
Locations:
city: Monfalcone
country: Italy
facility: Ospedale San Polo Monfalcone
state: Gorizia
city: San Daniele
country: Italy
facility: Ospedale di S. Antonio
state: Udine
city: San Vito Al Tagliamento
country: Italy
facility: Ospedale di San Vito al Tagliamento
state: Udine
city: Tolmezzo
country: Italy
facility: Ospedale di S. Antonio Abate
state: Udine
city: Pordenone
country: Italy
facility: Casa di Cura Policlinico San Giorgio
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
city: Udine
country: Italy
facility: Ospedale di Palmanova
city: Udine
country: Italy
facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Marzia Lazzerini, MD
role: STUDY_DIRECTOR
References: