Implementation of WHO Standards for Improving Maternal and Newborn Care

Perinatal Care Clinical Trial

— IMAgiNE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012591
• Other study ID #: RC 16/22
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 15, 2026

Study information

• Verified date: March 2024
• Source: IRCCS Burlo Garofolo
• Contact: Marzia Lazzerini, MD
• Phone: +390403785555
• Email: marzia.lazzerini[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perinatal Care

Intervention

Other:
• Quality improvement recommendations (action plans)
Developed and implemented at facility level to address key quality gaps emerging from the baseline assessment

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Maternal and Newborn Care Index evaluated by women	Evaluated by questionnaire	At hospital discharge (assessed up to day 5)
Primary	Quality of Maternal and Newborn Care Index evaluated by health professionals	Evaluated by questionnaire	At hospital discharge (assessed up to day 5)
Secondary	Frequency of caesarean section		At hospital discharge (assessed up to day 5)
Secondary	Frequency of episiotomy		At hospital discharge (assessed up to day 5)