Gynecologic DiseaseNCT03984617
Impact of Football Matches on the Emergency Admissions of a Level III Maternity During EURO 2016
An observational study of Gynecologic Disease, run by Central Hospital, Nancy, France.
Trial summary
Attendances at an emergency department (ED) are often considered to depend on different factors such as moonlight, welfare checks, weather, and major sporting events. Data regarding effects of large sporting events on the workload of ED often assessed decreased patient volume, especially male use. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Emergency visit in a French tertiary Maternity hospital (Maternity of Nancy)
- How many people
- 1,114 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2016to 10 Jul 2016
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients admitted to emergencies are informed of the protocol and a questionnaire is provided by the care team.
Who may be able to join
- All female patients admitted urgently to the Regional Maternity Hospital between June 10 and July 10, 2016
Who cannot join
- refusal of the patient
- information and understanding impossible
About this study
Attendances at an emergency department (ED) are often considered to depend on different factors such as moonlight, welfare checks, weather, and major sporting events. Data regarding effects of large sporting events on the workload of ED often assessed decreased patient volume, especially male use. Currently, no data are available on the effect of major televised sporting events on obstetrical visits. The aim of this study is to examine whether televised soccer games from a major sporting tournament, (Euro 2016) influence the level of attendance at an obstetrical ED and could have implications for women's welfare.
In the summer of 2016, France hosted the largest European sporting event of the year 2016: the European Football Championships (Euro 2016). A total of 51 games were played over a month, bringing together the biggest European teams. An observational, retrospective study is conducted during this period on the number of emergency visits in a French tertiary Maternity hospital (Maternity of Nancy).
- Conditions
- Gynecologic Disease
- Being tested
- Emergency visit in a French tertiary Maternity hospital (Maternity of Nancy)
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency visit in a French tertiary Maternity hospital (Maternity of Nancy)Other
total number of visits (hospitalizations and consultations)
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall number of maternity emergencies admissions during EURO 2016 (10June-10July)
Measured: At the end of EURO 2016 on 10th July 2016
Secondary outcomes (1)
Number of daily admissions and per 2 hours time slot every day from June 10th to July 10th
Measured: At the end of EURO 2016 on 10th July 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start10 Jun 2016
- Primary completion10 Jul 2016
- Study completion10 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984617
- Sponsor's protocol ID
- PSS 2016/EURO-VIAL/ER
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Football Matches on the Emergency Admissions of a Level III Maternity During EURO 2016
- ClinicalTrials.gov ID
- NCT03984617
- Acronym / sponsor ID
- PSS 2016/EURO-VIAL/ER
- Conditions
- Gynecologic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 10 Jul 2016 (actual)
- First posted
- 13 Jun 2019 (actual)
- 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.
Attendances at an emergency department (ED) are often considered to depend on different factors such as moonlight, welfare checks, weather, and major sporting events. Data regarding effects of large sporting events on the workload of ED often assessed decreased patient volume, especially male use. Currently, no data are available on the effect of major televised sporting events on obstetrical visits. The aim of this study is to examine whether televised soccer games from a major sporting tournament, (Euro 2016) influence the level of attendance at an obstetrical ED and could have implications for women's welfare.
In the summer of 2016, France hosted the largest European sporting event of the year 2016: the European Football Championships (Euro 2016). A total of 51 games were played over a month, bringing together the biggest European teams. An observational, retrospective study is conducted during this period on the number of emergency visits in a French tertiary Maternity hospital (Maternity of Nancy).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to emergencies are informed of the protocol and a questionnaire is provided by the care team.
Key inclusion criteria (1 listed)
- All female patients admitted urgently to the Regional Maternity Hospital between June 10 and July 10, 2016
Key exclusion criteria (2 listed)
- refusal of the patient
- information and understanding impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency visit in a French tertiary Maternity hospital (Maternity of Nancy)total number of visits (hospitalizations and consultations) | Other | – |
Primary outcome
Overall number of maternity emergencies admissions during EURO 2016 (10June-10July)
Time frame: At the end of EURO 2016 on 10th July 2016
1 secondary outcome
Number of daily admissions and per 2 hours time slot every day from June 10th to July 10th
Time frame: At the end of EURO 2016 on 10th July 2016
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 13 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Disease, run by Central Hospital, Nancy, 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 1 inclusion and 2 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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall number of maternity emergencies admissions during EURO 2016 (10June-10July) (time frame: At the end of EURO 2016 on 10th July 2016). 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 13 Jun 2019.