Modernizing Perinatal Syphilis Testing
This study is looking for pregnant individuals, new mothers, and newborns who are at risk for syphilis, as well as men and non-pregnant individuals with syphilis. The goal is to improve how we detect syphilis in mothers and babies. Researchers are comparing two new tests, the quantitative polymerase chain reaction (qPCR) assay and the Aptima transcription-mediated amplification (TMA) assay, against the current 2021 CDC guidelines for diagnosing syphilis. They want to see how well these new tests work and if syphilis in newborns is linked to problems with their brain development. The study aims to enroll 924 participants, and its current status is unclear.
- Study design
- This is an interventional study. It plans to enroll 924 participants.
- What's involved
- Samples will be collected from the mother/newborn pair at the time of birth. For neonates, samples will be collected up to 72 or 96 hours after birth.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured from the time of birth up to 72 or 96 hours after birth.
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Modernizing Perinatal Syphilis Testing
At a glance
Conditions
Where it's being run
9 sites across 4 statesStudy leadership
- Irene Stafford, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidumfrom the time of birth up to 96 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidumfrom the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
- Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilisfrom 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
- Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilisfrom 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
- Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilisfrom 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
- Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilisfrom 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
- Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilisfrom 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.