Stopped: funding not secured
A dramatic rise in syphilis has been recently reported in the US between 2000-2017, which was followed also by a dramatic rise in congenital syphilis (CS). In 2017 there were 918 CS cases reported in the United States, including 64 syphilitic stillbirths. In 2017, California (CA) had one of the highest syphilis rates among women and this was accompanied by a dramatic increase in CS cases. Approximately 40% of CS cases in the United States occurred from maternal infections acquired late in gestation, missed by current-early gestation only-prenatal screening. More frequent prenatal screening late in gestation is urgently needed. However, cost considerations and operational logistic limitations preclude implementation even in high risk regions. There is an urgent need for widespread implementation of more frequent prenatal screening using alternative cost-saving screening approaches. The Syphilis-Health-Check (SHC) point-of-care (POC) test is a well validated POC-test that is already commercially available in the US, is approved by the Federal Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA)-waived. POC prenatal syphilis screening late in gestation using a well validated POC-test (in addition to the standard early gestation-screening with laboratory-based tests) could provide a cost-saving complementary alternative that could benefit patients, mitigate the higher cost associated with more frequent testing, overcome operational limitations and contribute to the elimination of CS. Moreover, POC-neonatal and placental screening could provide an additional complementary safeguard approach to decrease missed/delayed CS diagnoses.
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Count of pregnant women with concordant test results between the SHC-POC test and the TT/NTT test at 24-28 weeks gestational age, as a measure of validation of the diagnostic accuracy of the SHC-POC-test
Timeframe: Between 24-28 weeks gestational age of study participants
Count of pregnant women with concordant test results between the SHC-POC test and maternal syphilis diagnosis at 24-28 weeks gestational age requiring treatment during gestation, as a measure of validation of the diagnostic accuracy of the SHC-POC test
Timeframe: Between 24-28 weeks gestational age of study participants
Incidence of Congenital Syphilis (N of congenital Syphilis cases/ N of total births), as a measure of efficacy of POC-prenatal syphilis screening at 24-28 weeks gestational age
Timeframe: At birth and up to 3 months of age of offsprings of study participants