Pelvic Inflammatory DiseaseNCT06756568
The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)
An observational study of Pelvic Inflammatory Disease, run by Superior University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Reduced Morbidity
- How many people
- 139 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Feb 2024to 16 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: to check the Pelvic Inflammatory Disease (PID) using Ultrasound
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Reduced Morbidity
- 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.
Reduced MorbidityDiagnostic test
Early and accurate diagnosis using ultrasound minimizes delays in treatment initiation, thereby preventing complications such as chronic pain and abscess formation. By reducing the severity and duration of the disease, ultrasound contributes to improved patient well-being and a quicker recovery trajectory.
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start18 Feb 2024
- Primary completion1 Jul 2024
- Study completion16 Feb 2025 (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.
- More trials run by Superior UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756568
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/037
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)
- ClinicalTrials.gov ID
- NCT06756568
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/037
- Conditions
- Pelvic Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 16 Feb 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- to check the Pelvic Inflammatory Disease (PID) using Ultrasound
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Reduced MorbidityEarly and accurate diagnosis using ultrasound minimizes delays in treatment initiation, thereby preventing complications such as chronic pain and abscess formation. By reducing the severity and duration of the disease, ultrasound contributes to improved patient well-being and a quicker recovery trajectory. | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Superior University at 1 site in Pakistan.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
ultrasound (time frame: 12 Months). 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 3 Jan 2025.