Sexually Transmitted DiseasesNCT03877263
Comparing Specimen Collection Techniques to Screen for Sexually Transmitted Infections in Pregnant Women: A Pilot Study
A study testing Endocervical swab for detection of STI and Vaginal swab for detection of STI in people with Sexually Transmitted Diseases, run by OhioHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- Endocervical swab for detection of STI and Vaginal swab for detection of STI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2019to 27 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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 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.
Read the detailed description
Chlamydia trachomatis and Neisseria gonorrhoeae are the two most commonly reported infectious diseases in the United States. Their role in pregnancy-related comorbidities such as spontaneous abortion, preterm labor, chorioamnionitis, preterm premature rupture of membranes, and perinatal infection is complicated as data is conflicting. Many reports suggest increased risks of adverse pregnancy outcomes in the presence of C. trachomatis and N. gonorrhoeae infections. However, there are also several studies that have failed to demonstrate an increased risk. Despite conflicting reports, due to high prevalence of these infections and association with pregnancy-related co-morbidities, the Center for Disease Control (CDC) recommends screening for C. trachomatis and N. gonorrhoeae in high-risk populations at initiation of prenatal care, and again during the third trimester to ensure infections are treated quickly and resolved prior to birth.
In the non-pregnant female population, there are many ways to screen for C. trachomatis and N. gonorrhoeae pelvic infections, including bacterial culture, direct fluorescent antibody testing, deoxyribonucleic acid (DNA) probe, enzyme immunoassay, or ribonucleic acid (RNA) amplification. These various testing modalities can be applied to urine, or vaginal or endocervical samplings. RNA assays and DNA probes are currently the least expensive and most accurate way of screening, and are therefore the most routinely used.
At OhioHealth Doctors Hospital (DH) Women's Health Center, pregnant patients are screened for sexually transmitted infections (STI) using the Hologic Aptima Chlamydia trachomatis and the Neisseria gonorrhoeae assays, which are second generation nucleic acid amplification assays (NAATs). Samples are collected using the Hologic Aptima Unisex Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens. These swabs are specifically designed for cervical swab collection techniques. Per standard of care at DH and CDC recommendations, patient endocervical swabs are collected at the patient's initial prenatal visit and during her third trimester appointment (approximately 36 week gestation) to test for infection.
In non-pregnant women, the vaginal specimen collection kit has been shown to be just as effective at detecting pelvic infections of C. trachomatis and N. gonorrhea using RNA assays. There are many benefits of adopting the use of a vaginal specimen collection kit, as compared to endocervical collection. Vaginal sampling can be performed without a speculum exam in asymptomatic women. In addition to being a less invasive test, the vaginal swab may reduce testing costs, by eliminating the use of collection tools (such as disposable speculums) that are required during an endocervical collection; avoiding the endocervical collection procedure may also reduce the overall office visit time. Additionally, patients could be instructed to collect a vaginal sample themselves. This may increase patient satisfaction, privacy, and comfort. In fact, several publications have reported patient preference for a self-collected vaginal swab vs. an endocervical swab.
Few studies have evaluated the used of vaginal or introital swabbing techniques for detection of infectious microorganisms during pregnancy, but the published data is favorable for the use of a vaginal swab. Thus, more data is needed to compare the use of vaginal vs. endocervical swabs to detect infections in pregnant women. The objective of this study is to compare detection of sexually transmitted infections in pregnant women by collecting samples using both the Hologic Aptima Vaginal Swab and the Unisex Specimen Collection Kit for Endocervical and Male Urethral Swab.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- Endocervical swab for detection of STI, Vaginal swab for detection of STI
- Keywords
- Chlamydia Trachomatis, Neisseria gonorrhoeae
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocervical swab for detection of STIDiagnostic test
After we collect the samples, they will be evaluated using the Hologic APTIMA Chlamydia trachomatis and Neisseria gonorrhoeae assays.
Vaginal swab for detection of STIDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Endocervical swab for detection of STI; Diagnostic Test: Vaginal swab for detection of STI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Assess the costs of medical supplies used during pelvic examinations.
Compare the costs of medical supplies used in endocervical vs vaginal sample collection techniques.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start12 Mar 2019
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Why it stopped: Principal investigator left the institution and study was not transferred to anyone else.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Topolnycky, DO, Study chair, Attending PhysicianKrista Jensen, DO, Principal investigator, Resident Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877263
- Sponsor's protocol ID
- 1297556
- Status last verified
- Feb 2021
- First submitted
- 14 Mar 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study data will be collected using study-specific data abstraction sheets/data collection tools (e.g., REDCap or Excel). Only institutional review board (IRB)-approved variables will be collected. Electronic files will be stored on a password-protected computer, and paper files will be stored in a secure facility with limited access (the offices of the OhioHealth Research Institute). Desktop or mobile computers used for research purposes will be password-protected and encrypted. Data transmitted over the internet or via email will be encrypted. All resulting data will be securely stored in electronic format according to OhioHealth policy; the data collection and storage processes will follow HIPAA guidelines in accordance to 45 Code of Federal Regulations (CFR) Part 160 \& 164, to protect both confidentiality and privacy of each participant. All protected health information (PHI) data will be released or destroyed per institution protocol.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Specimen Collection Techniques to Screen for Sexually Transmitted Infections in Pregnant Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT03877263
- Acronym / sponsor ID
- 1297556
- Conditions
- Sexually Transmitted Diseases
- Keywords
- Chlamydia Trachomatis, Neisseria gonorrhoeae
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left the institution and study was not transferred to anyone else.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chlamydia trachomatis and Neisseria gonorrhoeae are the two most commonly reported infectious diseases in the United States. Their role in pregnancy-related comorbidities such as spontaneous abortion, preterm labor, chorioamnionitis, preterm premature rupture of membranes, and perinatal infection is complicated as data is conflicting. Many reports suggest increased risks of adverse pregnancy outcomes in the presence of C. trachomatis and N. gonorrhoeae infections. However, there are also several studies that have failed to demonstrate an increased risk. Despite conflicting reports, due to high prevalence of these infections and association with pregnancy-related co-morbidities, the Center for Disease Control (CDC) recommends screening for C. trachomatis and N. gonorrhoeae in high-risk populations at initiation of prenatal care, and again during the third trimester to ensure infections are treated quickly and resolved prior to birth.
In the non-pregnant female population, there are many ways to screen for C. trachomatis and N. gonorrhoeae pelvic infections, including bacterial culture, direct fluorescent antibody testing, deoxyribonucleic acid (DNA) probe, enzyme immunoassay, or ribonucleic acid (RNA) amplification. These various testing modalities can be applied to urine, or vaginal or endocervical samplings. RNA assays and DNA probes are currently the least expensive and most accurate way of screening, and are therefore the most routinely used.
At OhioHealth Doctors Hospital (DH) Women's Health Center, pregnant patients are screened for sexually transmitted infections (STI) using the Hologic Aptima Chlamydia trachomatis and the Neisseria gonorrhoeae assays, which are second generation nucleic acid amplification assays (NAATs). Samples are collected using the Hologic Aptima Unisex Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens. These swabs are specifically designed for cervical swab collection techniques. Per standard of care at DH and CDC recommendations, patient endocervical swabs are collected at the patient's initial prenatal visit and during her third trimester appointment (approximately 36 week gestation) to test for infection.
In non-pregnant women, the vaginal specimen collection kit has been shown to be just as effective at detecting pelvic infections of C. trachomatis and N. gonorrhea using RNA assays. There are many benefits of adopting the use of a vaginal specimen collection kit, as compared to endocervical collection. Vaginal sampling can be performed without a speculum exam in asymptomatic women. In addition to being a less invasive test, the vaginal swab may reduce testing costs, by eliminating the use of collection tools (such as disposable speculums) that are required during an endocervical collection; avoiding the endocervical collection procedure may also reduce the overall office visit time. Additionally, patients could be instructed to collect a vaginal sample themselves. This may increase patient satisfaction, privacy, and comfort. In fact, several publications have reported patient preference for a self-collected vaginal swab vs. an endocervical swab.
Few studies have evaluated the used of vaginal or introital swabbing techniques for detection of infectious microorganisms during pregnancy, but the published data is favorable for the use of a vaginal swab. Thus, more data is needed to compare the use of vaginal vs. endocervical swabs to detect infections in pregnant women. The objective of this study is to compare detection of sexually transmitted infections in pregnant women by collecting samples using both the Hologic Aptima Vaginal Swab and the Unisex Specimen Collection Kit for Endocervical and Male Urethral Swab.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OB/GYN physician-collected vaginal swab | Other | Diagnostic Test: Endocervical swab for detection of STI, Diagnostic Test: Vaginal swab for detection of STIPatients 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. |
| Patient-collected vaginal swab | Other | Diagnostic Test: Endocervical swab for detection of STI, Diagnostic Test: Vaginal swab for detection of STIPatients 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocervical swab for detection of STIAfter we collect the samples, they will be evaluated using the Hologic APTIMA Chlamydia trachomatis and Neisseria gonorrhoeae assays. | Diagnostic test | OB/GYN physician-collected vaginal swab, Patient-collected vaginal swab |
| Vaginal swab for detection of STIAfter 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 | Diagnostic test | OB/GYN physician-collected vaginal swab, Patient-collected vaginal swab |
Primary outcome
Compare the physician-collected vaginal swab outcomes to those from the physician-collected endocervical swab.
Time frame: 12 months
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.
1 secondary outcome
Assess the costs of medical supplies used during pelvic examinations.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Principal investigator left the institution and study was not transferred to anyone else.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No. All study data will be collected using study-specific data abstraction sheets/data collection tools (e.g., REDCap or Excel). Only institutional review board (IRB)-approved variables will be collected. Electronic files will be stored on a password-protected computer, and paper files will be stored in a secure facility with limited access (the offices of the OhioHealth Research Institute). Desktop or mobile computers used for research purposes will be password-protected and encrypted. Data transmitted over the internet or via email will be encrypted. All resulting data will be securely stored in electronic format according to OhioHealth policy; the data collection and storage processes will follow HIPAA guidelines in accordance to 45 Code of Federal Regulations (CFR) Part 160 \& 164, to protect both confidentiality and privacy of each participant. All protected health information (PHI) data will be released or destroyed per institution protocol.
Related trials for Sexually Transmitted Diseases
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Not yet recruitingObservational study
HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)
HIV Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Topolnycky, DO study chair
Attending Physician
Krista Jensen, DO principal investigator
Resident Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocervical swab for detection of STI and Vaginal swab for detection of STI in people with Sexually Transmitted Diseases, run by OhioHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal investigator left the institution and study was not transferred to anyone else.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the physician-collected vaginal swab outcomes to those from the physician-collected endocervical swab. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.