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Activity and Quality of Care Indicators' for a Sentinel Network Creation

Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02274441
Acronym
URGO
Enrollment
2000
Registered
2014-10-24
Start date
2015-01-31
Completion date
2018-01-31
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecology, Maternal Morbidity, Obstetrics, Quality

Brief summary

There is no large-scale data in France or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. The creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research. The network will be designed to promote research in women's health and the emergency reception by focusing on: (i) Assessment of the quality and organization of care and professional practice for the management of gynecological emergencies. (ii) The study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) Comparison of organization systems gynecological emergencies departement between different high resource francophone countries (France, Switzerland, Belgium). (v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

Detailed description

Objectives : * To measure the incidence of the potentially life-threatening gynaecological emergencies (G-PLE) and of the Cases of severe morbidity (SM) * To analyze the determinants of the SM, * To validate an objective score of quality Criterias of evaluation: * Incidence of the G-PLE and SM cases during one month. * Reliability and validity of measurements of the indicators of quality of care. Methodology: Stage 1: Data acquisition (prospective) within 22 gynaecological emergencies departments. Stage 2: Sampling and checking of files of patients included at stage 1 Calendar of the research project: 18 months: * 6 months for the phase of preparation, * 1 month for the investigation of incidence, * 5 months for the phase of checking data, * 6 months of statistical analysis Statistical Analyzes: Descriptive statistics of the data. Estimation of the incidence rate of the potentially life-threatening gynaecological emergencies (G-PLE) and of the cases of Severe morbidity (SM) among women consulting for acute pelvic pain. To construct reliable quality indicators, principal components analysis and Cronbach's α statistics will be performed to determine the underlying dimensions. Construct validity of indicators will be assessed by testing predefined hypotheses about relationship between G-PLE and or SM and quality indicators.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* French-speaking gynaecological emergencies departments leaned with a public maternity volunteers to take part in the study. * Sample of files resulting from the principal centers recruiters

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Incidence of the potentially life-threatening gynaecological emergencies (G-PLE )1 year
Incidence of severe morbidity (SM) cases1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026