ObstetricsURGONCT02274441
Activity and Quality of Care Indicators' for a Sentinel Network Creation
An observational study of Obstetrics and Maternal Morbidity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obstetrics, Maternal Morbidity, Gynecology
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel
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:
Read more
(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.
Read the 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.
- Conditions
- Obstetrics, Maternal Morbidity, Gynecology, Quality
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the potentially life-threatening gynaecological emergencies (G-PLE )
Measured: 1 year
Incidence of severe morbidity (SM) cases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObstetricsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274441
- Sponsor's protocol ID
- NI12027
- Acronym
- URGO
- Status last verified
- Feb 2018
- First submitted
- 8 Oct 2014
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel
- ClinicalTrials.gov ID
- NCT02274441
- Acronym / sponsor ID
- URGO / NI12027
- Conditions
- Obstetrics, Maternal Morbidity, Gynecology, Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of the potentially life-threatening gynaecological emergencies (G-PLE )
Time frame: 1 year
Incidence of severe morbidity (SM) cases
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetrics and Maternal Morbidity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the potentially life-threatening gynaecological emergencies (G-PLE ) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.