Pelvic Inflammatory DiseaseNCT05648747
Pelvic Inflammatory Disease in COVID-19 Era
An observational study of Pelvic Inflammatory Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The goal of this retrospective cohort study is to to scrutinize the impact of coronavirus disease 2019 (COVID-19) on incidence, demography and patient characteristics in Pelvic Inflammatory Disease comparing with the equal time duration, before and after lockdown was initiated in the country. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- impact of COVID-19 on Health-Seeking Behaviors
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Jan 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A retrospective analysis of pelvic inflammatory disease in women was performed between March 8, 2020 and March 31, 2022 (COVID-19 period). The control period was collected between January , 2020 and December 31, 2019.
Who may be able to join
- Pelvic Inflammatory disease
Who cannot join
- Pregnancy Oncologic disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
Ferrara
Gennaro Scutiero, MD, +390532236576, gennaro.scutiero@unife.it
About this study
Official title: Factors Associated With an Unfavorable Clinical Course in Hospitalized Patients With Pelvic Inflammatory Disease in Post Covid 19 Era: a Multicentric Retrospective Cohort Study
The goal of this retrospective cohort study is to to scrutinize the impact of coronavirus disease 2019 (COVID-19) on incidence, demography and patient characteristics in Pelvic Inflammatory Disease comparing with the equal time duration, before and after lockdown was initiated in the country.
The main aim of this study was to compare the demographic and clinical parameters between two cohorts before the onset of lockdown and within the pandemic.
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- impact of COVID-19 on Health-Seeking Behaviors
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impact of COVID-19 on Health-Seeking BehaviorsOther
The impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Italy's government rapidly established diverse public actions, which helped maintain the medical supply. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether pelvic inflammatory disease rates were affected by the COVID-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| Complicated Pelvic Inflammatory Disease | The development of complicated Pelvic Inflammatory Disease diagnosed during laparoscopy or by pre-operative image study Receives: Other: impact of COVID-19 on Health-Seeking Behaviors | |
| Non-Complicated Pelvic Inflammatory Disease | No development of complicated Pelvic Inflammatory Disease diagnosed during laparoscopy or by pre-operative image study Receives: Other: impact of COVID-19 on Health-Seeking Behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pelvic inflammatory disease (PID)
The primary outcome measure was the occurrence of PID defined as abscess observed in computed tomography or a description of gangrenous salpingitis assessed by pathological reports.
Measured: baseline, pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Scutiero, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648747
- Sponsor's protocol ID
- 826/2022/Oss/AOUFe
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With an Unfavorable Clinical Course in Hospitalized Patients With Pelvic Inflammatory Disease in Post Covid 19 Era: a Multicentric Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05648747
- Acronym / sponsor ID
- 826/2022/Oss/AOUFe
- Conditions
- Pelvic Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 13 Dec 2022 (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.
The goal of this retrospective cohort study is to to scrutinize the impact of coronavirus disease 2019 (COVID-19) on incidence, demography and patient characteristics in Pelvic Inflammatory Disease comparing with the equal time duration, before and after lockdown was initiated in the country.
The main aim of this study was to compare the demographic and clinical parameters between two cohorts before the onset of lockdown and within the pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complicated Pelvic Inflammatory Disease | – | Other: impact of COVID-19 on Health-Seeking BehaviorsThe development of complicated Pelvic Inflammatory Disease diagnosed during laparoscopy or by pre-operative image study |
| Non-Complicated Pelvic Inflammatory Disease | – | Other: impact of COVID-19 on Health-Seeking BehaviorsNo development of complicated Pelvic Inflammatory Disease diagnosed during laparoscopy or by pre-operative image study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective analysis of pelvic inflammatory disease in women was performed between March 8, 2020 and March 31, 2022 (COVID-19 period). The control period was collected between January , 2020 and December 31, 2019.
Key inclusion criteria (1 listed)
- Pelvic Inflammatory disease
Key exclusion criteria (1 listed)
- Pregnancy Oncologic disease
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 |
|---|---|---|
| impact of COVID-19 on Health-Seeking BehaviorsThe impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Italy's government rapidly established diverse public actions, which helped maintain the medical supply. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether pelvic inflammatory disease rates were affected by the COVID-19 pandemic. | Other | Complicated Pelvic Inflammatory Disease, Non-Complicated Pelvic Inflammatory Disease |
Primary outcome
Incidence of pelvic inflammatory disease (PID)
Time frame: baseline, pre-surgery
The primary outcome measure was the occurrence of PID defined as abscess observed in computed tomography or a description of gangrenous salpingitis assessed by pathological reports.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
Ferrara, Italy
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 Pelvic Inflammatory Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pelvic inflammatory disease (PID) (time frame: baseline, pre-surgery). 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 Dec 2022.