Implementation of WHO Standards for Improving Maternal and Newborn Care

NCT ID: NCT06012591

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

9000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-01-15

Brief Summary

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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

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Conditions

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Perinatal Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before-after study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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WHO Standard implementation

Group Type OTHER

Quality improvement recommendations (action plans)

Intervention Type OTHER

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

Interventions

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Quality improvement recommendations (action plans)

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marzia Lazzerini, MD

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

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Ospedale San Polo Monfalcone

Monfalcone, Gorizia, Italy

Site Status RECRUITING

Ospedale di S. Antonio

San Daniele, Udine, Italy

Site Status RECRUITING

Ospedale di San Vito al Tagliamento

San Vito al Tagliamento, Udine, Italy

Site Status RECRUITING

Ospedale di S. Antonio Abate

Tolmezzo, Udine, Italy

Site Status ACTIVE_NOT_RECRUITING

Casa di Cura Policlinico San Giorgio

Pordenone, , Italy

Site Status RECRUITING

IRCCS Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

Ospedale di Palmanova

Udine, , Italy

Site Status RECRUITING

Presidio Ospedaliero Universitario Santa Maria della Misericordia

Udine, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marzia Lazzerini, MD

Role: CONTACT

+390403785555

Emanuelle Pessa Valente, MD

Role: CONTACT

Facility Contacts

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Dana Dragovic, MD

Role: primary

+390481 487252 - 592956

Role: primary

+390432 949274

Role: primary

+390434 841480

Role: primary

+390434519521

Marzia Lazzerini, MD

Role: primary

+390403785555

Elisabetta Miorin, MD

Role: primary

+390432-921414

Luigi Cattarossi, MD

Role: primary

+390432-552810

Other Identifiers

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RC 16/22

Identifier Type: -

Identifier Source: org_study_id

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