NCT05648747

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 9, 2022

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, pre-surgery

Study Arms (2)

Complicated Pelvic Inflammatory Disease

The development of complicated Pelvic Inflammatory Disease diagnosed during laparoscopy or by pre-operative image study

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

Other: impact of COVID-19 on Health-Seeking Behaviors

Interventions

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.

Complicated Pelvic Inflammatory DiseaseNon-Complicated Pelvic Inflammatory Disease

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Pelvic Inflammatory disease

You may not qualify if:

  • Pregnancy Oncologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy

Ferrara, Italy

RECRUITING

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Pelvic InfectionInfectionsAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 13, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 30, 2024

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations