Implementation of WHO Standards for Improving Maternal and Newborn Care (IMAgiNE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Perinatal Care
• Intervention / Treatment: Other: Quality improvement recommendations (action plans)

• Study Type: Interventional
• Enrollment (Estimated): 9000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marzia Lazzerini, MD; Phone Number: +390403785555; Email: marzia.lazzerini@burlo.trieste.it
• Study Contact Backup: Name: Emanuelle Pessa Valente, MD; Email: emanuelle.pessavalente@burlo.trieste.it

Study Locations

• Italy
  • Pordenone, Italy
    • Recruiting
    • Casa di Cura Policlinico San Giorgio
    • Contact: Phone Number: +390434519521
  • Trieste, Italy, 34137
    • Recruiting
    • IRCCS Burlo Garofolo
    • Contact: Marzia Lazzerini, MD; Phone Number: +390403785555; Email: marzia.lazzerini@burlo.trieste.it
  • Udine, Italy
    • Recruiting
    • Presidio Ospedaliero Universitario Santa Maria della Misericordia
    • Contact: Luigi Cattarossi, MD; Phone Number: +390432-552810; Email: luigi.cattarossi@asuiud.sanita.fvg.it
  • Udine, Italy
    • Recruiting
    • Ospedale di Palmanova
    • Contact: Elisabetta Miorin, MD; Phone Number: +390432-921414; Email: elisabetta.miorin@aas2.sanita.fvg.it
  • Gorizia
    • Monfalcone, Gorizia, Italy
      • Recruiting
      • Ospedale San Polo Monfalcone
      • Contact: Dana Dragovic, MD; Phone Number: +390481 487252 - 592956; Email: danica.dragovic@aas2.sanita.fvg.it
  • Udine
    • San Daniele, Udine, Italy
      • Recruiting
      • Ospedale di S. Antonio
      • Contact: Phone Number: +390432 949274
    • San Vito Al Tagliamento, Udine, Italy
      • Recruiting
      • Ospedale di San Vito al Tagliamento
      • Contact: Phone Number: +390434 841480
    • Tolmezzo, Udine, Italy
      • Active, not recruiting
      • Ospedale di S. Antonio Abate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: WHO Standard implementation	Other: Quality improvement recommendations (action plans); Developed and implemented at facility level to address key quality gaps emerging from the baseline assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Maternal and Newborn Care Index evaluated by women	Evaluated by questionnaire	At hospital discharge (assessed up to day 5)
Quality of Maternal and Newborn Care Index evaluated by health professionals	Evaluated by questionnaire	At hospital discharge (assessed up to day 5)

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of caesarean section	At hospital discharge (assessed up to day 5)
Frequency of episiotomy	At hospital discharge (assessed up to day 5)

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Marzia Lazzerini, MD, IRCCS Materno Infantile Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of care; quality improvement; WHO standards; maternal and newborn care
• Other Study ID Numbers: RC 16/22

Drug and device information, study documents

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