Pelvic Inflammatory Disease in COVID-19 Era

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Inflammatory Disease
• Intervention / Treatment: Other: impact of COVID-19 on Health-Seeking Behaviors

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy
    • Recruiting
    • Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
    • Contact: Gennaro Scutiero, MD; Phone Number: +390532236576; Email: gennaro.scutiero@unife.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

Inclusion Criteria:

Pelvic Inflammatory disease

Exclusion Criteria:

Pregnancy Oncologic disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Adnexal Diseases; Pelvic Inflammatory Disease; Pelvic Infection
• Other Study ID Numbers: 826/2022/Oss/AOUFe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No