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NCT03877263 · ClinicalTrials.gov registry record · NA
Comparing Specimen Collection Techniques to Screen for Sexually Transmitted Infections in Pregnant Women: A Pilot Study
A NA study, sponsored by OhioHealth.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT03877263: Clinical Trial NA study, sponsored by OhioHealth.
NCT03877263 is a NA study that was terminated before completion, run by OhioHealth. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03877263, a NA study, was terminated before completion, sponsored by OhioHealth.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
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.
Primary Outcome
Determine the rate of concordance for infection screening results between the physician collected vaginal and physician collected endocervical specimens in pregnant patients. Concordance will be defined as same results (whether positive or negative) on both methods.
Interventions
- DIAGNOSTIC_TEST Endocervical swab for detection of STI
- DIAGNOSTIC_TEST Vaginal swab for detection of STI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2019-09-27 |
| Phase | NA |
Why NCT03877263 stopped before completion
NCT03877263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Endocervical swab for detection of STI is the first listed.
NCT03877263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03877263 about?
NCT03877263 is a clinical study titled "Comparing Specimen Collection Techniques to Screen for Sexually Transmitted Infections in Pregnant Women: A Pilot Study". 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 specime...
What is the current status of trial NCT03877263?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2019-03-12. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT03877263?
The interventions under investigation include: Endocervical swab for detection of STI (DIAGNOSTIC_TEST), Vaginal swab for detection of STI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03877263?
This trial is sponsored by OhioHealth, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03877263's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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