Implementation of WHO Standards for Improving Maternal and Newborn Care

NCT06012591 | Recruiting

• 1 other identifier: RC 16/22
• Study Type: interventional
• Target: 9,000
• Locations: 1 country
• Sites: 8

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).

Conditions

Perinatal Care

Keywords

maternal and newborn care; quality of care; quality improvement; WHO standards

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Frequency of caesarean section

  At hospital discharge (assessed up to day 5)

• Frequency of episiotomy

  At hospital discharge (assessed up to day 5)

Study Arms (1)

WHO Standard implementation

OTHER

Other: Quality improvement recommendations (action plans)

Interventions

Quality improvement recommendations (action plans) OTHER

Developed and implemented at facility level to address key quality gaps emerging from the baseline assessment

WHO Standard implementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For women:
• \. Women who give birth at the nine maternity hospitals of the Friuli Venezia Giulia (FVG) Region, Italy
• For health workers
• \. 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 )

You may not qualify if:

• For women:
• Age \<18 years;
• Stillbirth or neonatal death;
• Psychiatric problems who may interfere with the telephone interview;
• Hidden pregnancy or women whose child has been adopted or placed in foster care;
• Refusal to participate.
• For health workers
• Refusal to participate;
• Prolonged absence with unavailability during the study period.

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (8)

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, 34137, Italy

RECRUITING

Ospedale di Palmanova

Udine, Italy

RECRUITING

Presidio Ospedaliero Universitario Santa Maria della Misericordia

Udine, Italy

RECRUITING

Study Officials

• Marzia Lazzerini, MD

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Central Study Contacts

Marzia Lazzerini, MD

CONTACT

+390403785555; marzia.lazzerini@burlo.trieste.it

Emanuelle Pessa Valente, MD

CONTACT

emanuelle.pessavalente@burlo.trieste.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before-after study

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: August 25, 2023
• Study Start: September 1, 2022
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: June 12, 2024

Record last verified: 2024-03

Locations

IT (8)