NCT06756568

Brief 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 as Neisseria gonorrhoeae and Chlamydia trachomation. However, it can also be associated with endogenous bacteria or occur following surgical procedures.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

February 18, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 26, 2024

Last Update Submit

December 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Months

Interventions

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPelvic Inflammatory Disease
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

to check the Pelvic Inflammatory Disease (PID) using Ultrasound

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Reading Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

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
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

February 18, 2024

Primary Completion

July 1, 2024

Study Completion

February 16, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations