- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756568
The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)
December 26, 2024 updated by: Muhammad Naveed Babur, Superior University
Pelvic inflammatory disease (PID) represents a significant and complex health issue affecting women, particularly those of reproductive age.
Characterized by the infection and inflammation of the reproductive organs, PID often results from ascending infections primarily caused by sexually transmitted pathogens, such as Neisseria gonorrhoeae and Chlamydia trachomation.
However, it can also be associated with endogenous bacteria or occur following surgical procedures.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The diverse manifestations of PID from asymptomatic cases to acute presentations, pose significant challenges in diagnosis and prompt treatment.
Accurate diagnosis is crucial, as untreated infections can lead to severe complications, including infertility, chronic pelvic pain, and ectopic pregnancies.
Study Type
Observational
Enrollment (Actual)
139
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Khyber Pakhtunkhwa
-
Peshawar, Khyber Pakhtunkhwa, Pakistan
- Lady Reading Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
to check the Pelvic Inflammatory Disease (PID) using Ultrasound
Description
Inclusion Criteria:
- Women of reproductive age (18-45 years) presenting with symptoms suggestive of pelvic inflammatory disease (PID).
- Patients who have been clinically diagnosed with PID based on symptoms such as lower abdominal pain, fever, abnormal vaginal discharge, and tenderness upon pelvic examination.
- Patients who have undergone preliminary diagnostic tests, such as high vaginal swab (HVS) and urine microscopy, culture, and sensitivity (m/c/s), prior to ultrasound assessment.
Exclusion Criteria:
- Pregnant women, due to potential confounding factors in ultrasound findings and differential diagnosis.
- Patients with chronic pelvic pain not related to acute PID episodes.
- Patients who do not provide informed consent for participation in the study.
- Patients with a history of recent pelvic surgery within the last 6 months, as postoperative changes may affect ultrasound findings.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ultrasound
Time Frame: 12 Months
|
Ultrasound (GE Logiq P7 convex probe.3.5-5MHz) imaging using a curvilinear transducer that provides a broad field of view, commonly used for evaluating abdominal and pelvic organs. Doppler flow characteristics which increased blood flow in the pelvic region, especially around the fallopian tubes or ovaries, as detected by color Doppler ultrasound, indicative of inflammation. |
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2024
Primary Completion (Actual)
July 1, 2024
Study Completion (Estimated)
February 16, 2025
Study Registration Dates
First Submitted
December 26, 2024
First Submitted That Met QC Criteria
December 26, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 26, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSAHS/Batch-Spring23/037
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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