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

NCT02274441 | Completed

• 1 other identifier: NI12027
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetrics; Maternal Morbidity; Gynecology; Quality

Outcome Measures

Primary Outcomes (2)

• Incidence of the potentially life-threatening gynaecological emergencies (G-PLE )

  1 year

• Incidence of severe morbidity (SM) cases

  1 year

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Number of centers : 22 French-speaking gynaecological emergencies departments leaned with a public maternity Number of subjects expected: 2000 consultations for acute pelvic pain, 200 patients hospitalized for data-gathering stage; 408 records for checking data stage

You may qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Poissy Saint Germain Hospital

Poissy, 78180, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 24, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-02

Locations

FR (1)