IMAgiNE: Implementation of WHO Standards for Improving Maternal and Newborn Care

Sponsor
IRCCS Burlo Garofolo (Other)
Overall Status
Recruiting
CT.gov ID
NCT06012591
Collaborator
(none)
9,000
1
1
76.5
117.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Quality improvement recommendations (action plans)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Before-after studyBefore-after study
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Implementation of WHO Standards for Improving the Quality of Maternal-neonatal Care
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Jan 15, 2026
Anticipated Study Completion Date :
Jan 15, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Quality of Maternal and Newborn Care Index evaluated by women [At hospital discharge (assessed up to day 5)]

    Evaluated by questionnaire

  2. 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

  1. Frequency of caesarean section [At hospital discharge (assessed up to day 5)]

  2. Frequency of episiotomy [At hospital discharge (assessed up to day 5)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Burlo Garofolo Trieste Italy 34137

Sponsors and Collaborators

  • IRCCS Burlo Garofolo

Investigators

  • Study Director: Marzia Lazzerini, MD, IRCCS materno infantile Burlo Garofolo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT06012591
Other Study ID Numbers:
  • RC 16/22
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by IRCCS Burlo Garofolo

Study Results

No Results Posted as of Aug 25, 2023