Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns
Public ClinicalTrials.gov record NCT03814096. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns: A Proof of Concept Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03814096
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Interventions
- Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ) Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2019
- Primary completion
- Oct 28, 2022
- Completion
- Oct 28, 2023
- Last update posted
- Dec 12, 2019
2019 – 2023
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Santa Clara Valley Medical Center; Department of Obstetrics & Gynecology and Pediatrics | San Jose | California | 95128 | — |
| Stanford University School of Medicine, Department of Pediatrics, Division of Infectious Diseases | Stanford | California | 94305 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03814096, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 12, 2019 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03814096 live on ClinicalTrials.gov.