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Comparing Specimen Collection Techniques to Screen for Sexually Transmitted Infections in Pregnant Women: A Pilot Study

NCT03877263 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-02-05

No results posted yet for this study

Summary

The purpose of this research study is to compare two specimen collection techniques (vaginal vs. endocervical swab) to screen for sexually transmitted infections in pregnant women. Either a physician or the patient may collect the vaginal specimen; the physician will collect the endocervical specimen during a standard-of-care pelvic exam. Each technique utilizes a specialized swab for specimen collection. We will used the Hologic Aptima C. trachomatis and N. gonorrhoeae detection assay to analyze both specimens.

We hypothesize that the results from the physician-collected vaginal specimen will have equivalent outcomes those from the physician-collected endocervical specimen. If the techniques are equivalent for detecting infection, there may be an opportunity for cost saving and increased patient satisfaction with the vaginal technique, especially using patient-collected vaginal specimen collection.

Conditions

  • Sexually Transmitted Diseases

Interventions

DIAGNOSTIC_TEST

Endocervical swab for detection of STI

After we collect the samples, they will be evaluated using the Hologic APTIMA Chlamydia trachomatis and Neisseria gonorrhoeae assays.

DIAGNOSTIC_TEST

Vaginal swab for detection of STI

After we collect the samples, they will be evaluated using the Hologic APTIMA Chlamydia trachomatis and Neisseria gonorrhoeae assays. We will then compare the results from a vaginal vs. endocervical specimens within and between the groups

Sponsors & Collaborators

  • OhioHealth

    lead OTHER

Principal Investigators

  • Diana Topolnycky, DO · Attending Physician

  • Krista Jensen, DO · Resident Physician

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2019-09-27
Completion
2019-09-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877263 on ClinicalTrials.gov