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

NCT03877263 | Terminated

• 1 other identifier: 1297556
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chlamydia Trachomatis; Neisseria gonorrhoeae

Outcome Measures

Primary Outcomes (1)

• Compare the physician-collected vaginal swab outcomes to those from the physician-collected endocervical swab.

  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.

  12 months

Secondary Outcomes (1)

• Assess the costs of medical supplies used during pelvic examinations.

  12 months

Other Outcomes (1)

• Patient satisfaction following specimen collection.

  12 months

Study Arms (2)

OB/GYN physician-collected vaginal swab

OTHER

Patients assigned to the physician-collected vaginal swab group will have their Vaginal swab for detection of STI collected by their obstetrics and gynecology (OB/GYN) physician. The vaginal swabs will be collected first for all patients, to avoid any swab contact with lubricant. As standard of care, the physician will collect Endocervical swab for detection of STI for this group.

Diagnostic Test: Endocervical swab for detection of STI; Diagnostic Test: Vaginal swab for detection of STI

Patient-collected vaginal swab

OTHER

Patients assigned to the patient-collected vaginal swab group will self-collect the Vaginal swab for detection of sexually transmitted infection (STI). Patients who self-collect will receive instructions from their OB/GYN physician and in paper form. The vaginal swabs will be collected first for all patients, to avoid any swab contact with lubricant. As standard of care, the physician will collect Endocervical swab for detection of STI for this group.

Diagnostic Test: Endocervical swab for detection of STI; Diagnostic Test: Vaginal swab for detection of STI

Interventions

Endocervical swab for detection of STI DIAGNOSTIC_TEST

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

OB/GYN physician-collected vaginal swab; Patient-collected vaginal swab

Vaginal swab for detection of STI DIAGNOSTIC_TEST

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

OB/GYN physician-collected vaginal swab; Patient-collected vaginal swab

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

OhioHealth Doctors Hospital

Columbus, Ohio, 43228, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana Topolnycky, DO

  Attending Physician

  STUDY CHAIR

• Krista Jensen, DO

  Resident Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients agreeing to participate in the study will be randomized by visit into a study group in a 1:1 fashion. Patients who participate during both their initial and third trimester (of pregnancy) will be randomized twice to a study group. The randomization allocation schedule will be developed by biostatisticians from the OhioHealth Research \& Innovation Institute (OHRI), and will be hidden from the investigator until directly prior to enrollment to prevent bias. The clinical research coordinator will reveal the randomization allocation once patient is consented and enrolled into the study. Due to the nature of the study, we cannot completed mask the investigator from the study group while taking the vaginal swabs.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: March 12, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)