Implementation of WHO Standards for Improving Maternal and Newborn Care

Not Applicable

Recruiting

• Conditions: Perinatal Care
• Interventions: Other: Quality improvement recommendations (action plans)

• Registration Number: NCT06012591
• Lead Sponsor: IRCCS Burlo Garofolo

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WHO Standard implementation	Quality improvement recommendations (action plans)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequency of episiotomy	At hospital discharge (assessed up to day 5)
Frequency of caesarean section	At hospital discharge (assessed up to day 5)

Trial Locations

Locations (8)

Casa di Cura Policlinico San Giorgio; 🇮🇹 Pordenone, Italy

Ospedale di S. Antonio; 🇮🇹 San Daniele, Udine, Italy

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy

Ospedale di Palmanova; 🇮🇹 Udine, Italy

Presidio Ospedaliero Universitario Santa Maria della Misericordia; 🇮🇹 Udine, Italy

Ospedale di S. Antonio Abate; 🇮🇹 Tolmezzo, Udine, Italy

Ospedale San Polo Monfalcone; 🇮🇹 Monfalcone, Gorizia, Italy

Ospedale di San Vito al Tagliamento; 🇮🇹 San Vito Al Tagliamento, Udine, Italy