Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns
Withdrawn before enrolling · Not applicable
Conditions studied: Maternal Syphilis During Pregnancy - Baby Not Yet Delivered, Congenital Syphilis
In brief
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.
Key facts
- Study ID
- NCT03814096
- Run by
- Stanford University
- People needed
- 0
- Starts
- 2019-10-30
- Expected to finish
- 2023-10-29
- Last updated by the study team
- 2019-12-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Consenting adult pregnant women between 24-28 weeks GA seen at Obstetrics/Gynecology (OB/GYN) prenatal-care clinics in Santa Clara Valley Medical Center San Jose CA, at the time of their routine clinic visit at 24-28 weeks GA for their routine glucose-tolerance-test (GTT) prenatal screening.
You may not qualify if…
- Non-adult pregnant patients <18 years of age and pregnant women not between 24-28 weeks gestational age at the time of the clinic visit.
Where it is running
- Santa Clara Valley Medical Center; Department of Obstetrics & Gynecology and Pediatrics — San Jose, California, United States
- Stanford University School of Medicine, Department of Pediatrics, Division of Infectious Diseases — Stanford, California, United States
Full record on ClinicalTrials.gov
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