Maternal Syphilis During Pregnancy - Baby Not Yet DeliveredNCT03814096
Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns
A study testing Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ) in people with Maternal Syphilis During Pregnancy - Baby Not Yet Delivered and Congenital Syphilis, run by Stanford University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Syphilis During Pregnancy - Baby Not Yet Delivered, Congenital Syphilis
- What is being tested?
- Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2019to 29 Oct 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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
About this study
Official title: Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns: A Proof of Concept Study
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.
Read the detailed description
Given the dramatic rise in syphilis that has been recently reported in the United States in the recent years (between 2000-2017) there is an urgent need for widespread implementation of more frequent prenatal syphilis 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 United States, is approved by the Federal Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA)-waived. Hypotheses: a) Point-Of-Care (POC) prenatal syphilis screening late in gestation using a well validated POC-test (in addition to the standard early gestation-screening with lab-based tests) could provide a cost-saving complementary alternative that could benefit patients, mitigate the higher cost associated with the need for more frequent syphilis screening, overcome operational limitations and contribute to the elimination of CS. b) POC-neonatal screening can provide additional complementary safeguard approach to decrease missed/delayed CS diagnoses. POC-neonatal syphilis screening can be used as a rapid screening tool to capture/probe all neonatal cases who would need immediate medical attention and further investigation and workup to rule out (or rule-in accordingly) suspected/probable CS.
Specific Aim 1: Validate the diagnostic accuracy of SHC-POC-test in late gestation (24-28 weeks): a) against standard laboratory based syphilis treponemal tests (TT)/and non-treponemal tests (NTT) in prenatal-care clinic settings and b) also against clinical diagnoses of maternal syphilis requiring treatment during gestation (co-primary endpoint). Specific aim 2: Test the feasibility of POC-prenatal screening (secondary endpoint) and efficacy of POC-prenatal screening to decrease the incidence of CS in a high risk region, through prompt diagnosis (and treatment accordingly) of maternal syphilis cases that need immediate treatment (to prevent mother-to -child transmission) (co-primary endpoint). Specific Aim 3: Evaluate the feasibility of POC-neonatal screening and POC-placental screening and the concordance of the results between late gestation maternal, neonatal and placental POC-test results. (Proof of concept; secondary endpoints).
Study design: (a) Prospective cohort study in the Santa Clara Valley Medical Center (SCVMC), San Jose, CA over a 3 yr study period with enrollment of pregnant women at 24-28 weeks (wks) gestational age (GA), presenting for their routine clinic visit at 24-28 wks for their glucose tolerance test (GTT). SCVMC recently introduced as a new standard of care rescreening for syphilis of all pregnant women at 24-28 wks with TT/NTTs, bundled to the venipuncture for the Glucose Tolerance Test (GTT). During this clinic visit, the syphilis POC-testing will be done via a fingerstick in clinic, while the standard lab-based syphilis screening will be done via venipuncture in the lab (as part of the new standard of care). (b) Proof-of-concept prospective cohort substudy to test the feasibility of neonatal POC-testing (whole-blood collected via heel stick, bundled with the routine newborn screening for inborn errors of metabolism at 24-48 hours of life) and placental-POC-testing.
- Being tested
- Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)
- Keywords
- Syphilis, prenatal screening, SHC, point-of-care test
- Medical subject headings
- Syphilis, Congenital, Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)Diagnostic test
Syphilis Health Check (SHC) POC-test is a treponemal POC-test based on 3d generation enzyme immunoassay (EIA) method detecting both Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies.
| Study group | Role | What they receive |
|---|---|---|
| Syphilis POC-prenatal screening | Experimental | Syphilis prenatal screening late in gestation at 24-28 weeks (at the time of the routine prenatal care clinic visit for the routine Glucose Tolerance Test [GTT]) using the Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ) Receives: Diagnostic Test: Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Diagnostic accuracy of SHC-POC test against standard laboratory diagnostic tests for syphilis (TT/NTT) in late gestation (24-28 weeks)
Measured: 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
Diagnostic accuracy of SHC-POC test against maternal syphilis diagnosis late in gestation requiring treatment during gestation (24-28 weeks)
Measured: 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
The efficacy of SHC-POC prenatal screening in decreasing the incidence of Congenital Syphilis will be calculated. Comparison will be made between the incidence rate of Congenital Syphilis cases before the SHC-POC-prenatal screening (among all births in Santa Clara Valley Medical Center, San Jose, CA in the year before the SHC-POC-prenatal screening) and 3 years after the implementation of the SHC POC-prenatal screening (among all births from the screened participating pregnant women)
Measured: At birth and up to 3 months of age of offsprings of study participants
Secondary outcomes (1)
Count of concordant SHC-POC-test results between maternal, placental and neonatal SHC-POC-testing.
As a proof of concept, testing with the SHC-POC test also the placenta (at the time of delivery) and the offsprings of a minimum 20 consenting pregnant women will be done. The counts of SHC-POC test results that were concordant in the mothers, placentas and newborns will be calculated.
Measured: At 24-28 weeks gestational age of study participants (for maternal POC-test results); During Delivery (for placental POC-test results) and at birth and up to 3 months of age of offsprings of study participants (for neonatal POC-test results)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start30 Oct 2019 (estimated)
- Primary completion29 Oct 2022 (estimated)
- Study completion29 Oct 2023 (estimated)
Why it stopped: funding not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Syphilis During Pregnancy - Baby Not Yet DeliveredStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Responsible party
- Principal investigator, Despina Contopoulos-Ioannidis, Stanford University
- Investigators
- Despina G. Contopoulos-Ioannidis, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814096
- Sponsor's protocol ID
- 49086
- Status last verified
- Dec 2019
- First submitted
- 18 Jan 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We plan to share the study protocol and the study analysis plan. The informed consent forms and the database with the completely de-identified patient data (without any Personal Health Information (PHI)) will become available upon request from the study Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03814096
- Acronym / sponsor ID
- 49086
- Keywords
- Syphilis, prenatal screening, SHC, point-of-care test
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 29 Oct 2022 (estimated)
- Study completion
- 29 Oct 2023 (estimated)
- First posted
- 23 Jan 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.
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.
Detailed description
Given the dramatic rise in syphilis that has been recently reported in the United States in the recent years (between 2000-2017) there is an urgent need for widespread implementation of more frequent prenatal syphilis 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 United States, is approved by the Federal Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA)-waived. Hypotheses: a) Point-Of-Care (POC) prenatal syphilis screening late in gestation using a well validated POC-test (in addition to the standard early gestation-screening with lab-based tests) could provide a cost-saving complementary alternative that could benefit patients, mitigate the higher cost associated with the need for more frequent syphilis screening, overcome operational limitations and contribute to the elimination of CS. b) POC-neonatal screening can provide additional complementary safeguard approach to decrease missed/delayed CS diagnoses. POC-neonatal syphilis screening can be used as a rapid screening tool to capture/probe all neonatal cases who would need immediate medical attention and further investigation and workup to rule out (or rule-in accordingly) suspected/probable CS.
Specific Aim 1: Validate the diagnostic accuracy of SHC-POC-test in late gestation (24-28 weeks): a) against standard laboratory based syphilis treponemal tests (TT)/and non-treponemal tests (NTT) in prenatal-care clinic settings and b) also against clinical diagnoses of maternal syphilis requiring treatment during gestation (co-primary endpoint). Specific aim 2: Test the feasibility of POC-prenatal screening (secondary endpoint) and efficacy of POC-prenatal screening to decrease the incidence of CS in a high risk region, through prompt diagnosis (and treatment accordingly) of maternal syphilis cases that need immediate treatment (to prevent mother-to -child transmission) (co-primary endpoint). Specific Aim 3: Evaluate the feasibility of POC-neonatal screening and POC-placental screening and the concordance of the results between late gestation maternal, neonatal and placental POC-test results. (Proof of concept; secondary endpoints).
Study design: (a) Prospective cohort study in the Santa Clara Valley Medical Center (SCVMC), San Jose, CA over a 3 yr study period with enrollment of pregnant women at 24-28 weeks (wks) gestational age (GA), presenting for their routine clinic visit at 24-28 wks for their glucose tolerance test (GTT). SCVMC recently introduced as a new standard of care rescreening for syphilis of all pregnant women at 24-28 wks with TT/NTTs, bundled to the venipuncture for the Glucose Tolerance Test (GTT). During this clinic visit, the syphilis POC-testing will be done via a fingerstick in clinic, while the standard lab-based syphilis screening will be done via venipuncture in the lab (as part of the new standard of care). (b) Proof-of-concept prospective cohort substudy to test the feasibility of neonatal POC-testing (whole-blood collected via heel stick, bundled with the routine newborn screening for inborn errors of metabolism at 24-48 hours of life) and placental-POC-testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syphilis POC-prenatal screening | Experimental | Diagnostic Test: Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)Syphilis prenatal screening late in gestation at 24-28 weeks (at the time of the routine prenatal care clinic visit for the routine Glucose Tolerance Test [GTT]) using the Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)Syphilis Health Check (SHC) POC-test is a treponemal POC-test based on 3d generation enzyme immunoassay (EIA) method detecting both Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies. | Diagnostic test | Syphilis POC-prenatal screening |
Primary outcome
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
Time frame: Between 24-28 weeks gestational age of study participants
Diagnostic accuracy of SHC-POC test against standard laboratory diagnostic tests for syphilis (TT/NTT) in late gestation (24-28 weeks)
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
Time frame: Between 24-28 weeks gestational age of study participants
Diagnostic accuracy of SHC-POC test against maternal syphilis diagnosis late in gestation requiring treatment during gestation (24-28 weeks)
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
Time frame: At birth and up to 3 months of age of offsprings of study participants
The efficacy of SHC-POC prenatal screening in decreasing the incidence of Congenital Syphilis will be calculated. Comparison will be made between the incidence rate of Congenital Syphilis cases before the SHC-POC-prenatal screening (among all births in Santa Clara Valley Medical Center, San Jose, CA in the year before the SHC-POC-prenatal screening) and 3 years after the implementation of the SHC POC-prenatal screening (among all births from the screened participating pregnant women)
1 secondary outcome
Count of concordant SHC-POC-test results between maternal, placental and neonatal SHC-POC-testing.
Time frame: At 24-28 weeks gestational age of study participants (for maternal POC-test results); During Delivery (for placental POC-test results) and at birth and up to 3 months of age of offsprings of study participants (for neonatal POC-test results)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: Yes. We plan to share the study protocol and the study analysis plan. The informed consent forms and the database with the completely de-identified patient data (without any Personal Health Information (PHI)) will become available upon request from the study Principal Investigator.
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.
Despina G. Contopoulos-Ioannidis, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ) in people with Maternal Syphilis During Pregnancy - Baby Not Yet Delivered and Congenital Syphilis, run by Stanford University at 2 sites 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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?
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 (time frame: Between 24-28 weeks gestational age of study participants). The study lists 3 primary outcomes in all. 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 13 Dec 2019; AzTrials last refreshed its copy on 26 Oct 2026.