Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
Study NCT ID:
NCT06756568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}], 'ancestors': [{'id': 'D034161', 'term': 'Pelvic Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-02-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasound', 'timeFrame': '12 Months', 'description': '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.\n\nDoppler 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Inflammatory Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'to check the Pelvic Inflammatory Disease (PID) using Ultrasound', 'genderDescription': 'Pelvic Inflammatory Disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of reproductive age (18-45 years) presenting with symptoms suggestive of pelvic inflammatory disease (PID).\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Pregnant women, due to potential confounding factors in ultrasound findings and differential diagnosis.\n* Patients with chronic pelvic pain not related to acute PID episodes.\n* Patients who do not provide informed consent for participation in the study.\n* Patients with a history of recent pelvic surgery within the last 6 months, as postoperative changes may affect ultrasound findings.'}, 'identificationModule': {'nctId': 'NCT06756568', 'briefTitle': 'The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)', 'orgStudyIdInfo': {'id': 'MSAHS/Batch-Spring23/037'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Reduced Morbidity', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Lady Reading Hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}