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

Stopped early · Not applicable

Conditions studied: Sexually Transmitted Diseases

In brief

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.

Key facts

Study ID

NCT03877263

Run by

OhioHealth

People needed

17

Starts

2019-03-12

Expected to finish

2019-09-27

Last updated by the study team

2021-02-05

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant \& receiving prenatal care at Doctors Hospital Women's Health Center
• ≥16 years old
• Able to understand \& consent to study participation
• English speaking \& reading; if minor assent form is required, the parent or guardian must also be English speaking \& reading

You may not qualify if…

• Females who are not pregnant.
• <16 years old.
• Not english speaking \& reading; if minor assent form is required, the parent or guardian are not english speaking \& reading

Where it is running

• OhioHealth Doctors Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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