Improving maternal and newborn care using WHO standards

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

This study is testing how using World Health Organization standards can improve the care that mothers and newborns receive in hospitals in the Friuli Venezia Giulia region of Italy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 9000 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: IRCCS Burlo Garofolo (Academic / other)
• Locations: 8 sites (Monfalcone, Gorizia and 7 other locations)
• Trial ID: NCT06012591 on ClinicalTrials.gov

What this trial studies

This project aims to enhance the quality of maternal and newborn care in the Friuli Venezia Giulia region of Italy by implementing the World Health Organization's standards for quality improvement. It involves assessing care quality through a set of 318 quality measures that focus on the experience of care, provision of care, and availability of resources. The initiative targets all maternity hospitals in the region and includes both women giving birth and health workers involved in maternal and neonatal care. Quality improvement recommendations will be developed based on the assessment results.

Who should consider this trial

Good fit: Ideal candidates for this initiative are women giving birth at the nine maternity hospitals in the Friuli Venezia Giulia region.

Not a fit: Patients who may not benefit include those under 18 years of age, those experiencing stillbirth or neonatal death, and women with psychiatric issues that interfere with participation.

Why it matters

Potential benefit: If successful, this initiative could significantly reduce maternal and neonatal mortality rates by improving the quality of care provided during childbirth.

How similar studies have performed: Other studies implementing WHO standards for maternal and newborn care have shown positive outcomes, indicating that this approach is supported by existing evidence.

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.

Where this trial is running

Monfalcone, Gorizia and 7 other locations

• Ospedale San Polo Monfalcone — Monfalcone, Gorizia, Italy (Recruiting)
• Ospedale di S. Antonio — San Daniele, Udine, Italy (Recruiting)
• Ospedale di San Vito al Tagliamento — San Vito Al Tagliamento, Udine, Italy (Recruiting)
• Ospedale di S. Antonio Abate — Tolmezzo, Udine, Italy (Active_not_recruiting)
• Casa di Cura Policlinico San Giorgio — Pordenone, Italy (Recruiting)
• IRCCS Burlo Garofolo — Trieste, Italy (Recruiting)
• Ospedale di Palmanova — Udine, Italy (Recruiting)
• Presidio Ospedaliero Universitario Santa Maria della Misericordia — Udine, Italy (Recruiting)

Study contacts

• Study coordinator: Marzia Lazzerini, MD

Conditions Perinatal Care; maternal and newborn care; quality of care; quality improvement; WHO standards