Congenital SyphilisNCT05975502
Congenital Syphilis in Switzerland
An observational study of Congenital Syphilis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
A retrospective national epidemiological Swiss study was conducted to establish a real prevalence and description of congenital syphilis, and to better classify the reported congenital syphilis. Maternal risk factors to contract syphilis (i.e. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Syphilis
- What is being tested?
- Epidemiological study
- How many people
- 265 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Oct 2022to 4 Jul 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All pregnant women with a positive syphilis screening and their babies until age 6 from university and cantonal hospitals in Switzerland (Geneva, Lausanne, Zurich, Bern, Basel, Saint Gallen, Valais, Lugano) in dermatology, paediatric and gynaecology wards. Retrospective analysis of data from medical records.
Who may be able to join
- All pregnant women who had a positive TPHA / TPPA serology during pregnancy.
- All children born to mothers who had syphilis diagnosed during pregnancy or / and with a positive TPHA / TPPA serology.
Who cannot join
- Document in the medical file attesting to a refusal of consent to the re-use of the data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Congenital Syphilis in Switzerland: a National Multicentric Retrospective Epidemiological Study
A retrospective national epidemiological Swiss study was conducted to establish a real prevalence and description of congenital syphilis, and to better classify the reported congenital syphilis.
Maternal risk factors to contract syphilis (i.e. socio-demographic, cultural and clinical factors) were also evaluated, in order to focus on prevention of these targeted population.
Follow up of the children born from mother with syphilis during pregnancy, until age 6, was recorded to evaluate the risk of congenital syphilis following treatment of maternal syphilis.
Read the detailed description
We conducted an observational and descriptive retrospective multicentric national study in Switzerland of all pregnant women diagnosed with syphilis during their pregnancy and their babies from childbirth to age 6.
Retrospective clinical and biological data already collected in the patient's medical file from 2012 until 2021 were collected from pregnant women diagnosed with syphilis during their pregnancy and their babies from childbirth to age 6, in Swiss universities and cantonal hospitals.
Cases were collected through the computerized laboratory records by selecting all pregnant women with a positive TPHA / TPPA serology and children born to mothers who had syphilis diagnosed during pregnancy or / and with a positive TPHA / TPPA serology. Data collected included clinical information's, results of biological tests and imagery available from the hospital's internal archiving system and registered on two standardized coded case report forms (one for the mother and one for the babies).
Recent guidelines from the Centers for Disease Control recommend testing for syphilis at the first prenatal visit and again at 28 weeks gestation and at delivery if at high risk for syphilis acquisition during pregnancy. The identification, through the collection of epidemiological data, of risk factors for developing congenital syphilis during pregnancy may improve the prevention of congenital syphilis in the population at risk. It would make it possible to carry out preventive actions, repeated screening of syphilis during pregnancy and closer monitoring in a targeted population of women of childbearing age.
Thus, a proactive sentinel network could be developed to limit new cases of congenital syphilis in Switzerland, with the development of tools that could send alerts to the various specialists involved (biologist, gynaecologist, paediatrician, dermatologist) when a syphilis serology comes back positive in a pregnant woman.
This project is part of one of WHO's goals to eradicate congenital syphilis, as a better knowledge of congenital syphilis could lead us to propose solutions intended to reduce this serious disease. All the more that congenital syphilis is preventable by syphilis pregnancy screening and the burden of congenital syphilis is avoidable with a simple cost-effective treatment.
- Conditions
- Congenital Syphilis
- Being tested
- Epidemiological study
- Keywords
- Congenital syphilis, pregnant women with syphilis
- Medical subject headings
- Syphilis, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological studyOther
Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with positive syphilis serology | Pregnant women with blood TPHA/TPPA ≥ 80 Receives: Other: Epidemiological study | |
| Children born with positive syphilis serology | Children born from mothers with syphilis during pregnancy and / or with blood TPHA/TPPA ≥ 80 at birth Receives: Other: Epidemiological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the number of syphilis cases during pregnancy and the number of congenital syphilis cases.
Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.
Measured: Ten years: 2012 - 2021
To describe maternal characteristics associated with congenital syphilis (i.e. socio-demographic, cultural and clinical factors), in order to focus on prevention of these targeted population.
Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.
Measured: Ten years: 2012 - 2021
Secondary outcomes (1)
To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.
Measured: Ten years: 2012 - 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start19 Oct 2022
- Primary completion30 Jun 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital SyphilisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds national Suisse
- Responsible party
- Principal investigator, Laurence Toutous Trellu, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975502
- Sponsor's protocol ID
- Study 2022-01296
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kimball A, Bowen VB, Miele K, Weinstock H, Thorpe P, Bachmann L, McDonald R, Machefsky A, Torrone E. Congenital Syphilis Diagnosed Beyond the Neonatal Period in the United States: 2014-2018. Pediatrics. 2021 Sep;148(3):e2020049080. doi: 10.1542/peds.2020-049080.
PubMed 34465590Salome S, Cambriglia MD, Scarano SM, Capone E, Betts I, Pacella D, Sansone M, Mazzarelli LL, Lo Vecchio A, Ranucci G, Marinosci GZ, Capasso L, Salvatore P, Raimondi F. Congenital syphilis in the twenty-first century: an area-based study. Eur J Pediatr. 2023 Jan;182(1):41-51. doi: 10.1007/s00431-022-04703-5. Epub 2022 Nov 14.
PubMed 36376519Townsend CL, Francis K, Peckham CS, Tookey PA. Syphilis screening in pregnancy in the United Kingdom, 2010-2011: a national surveillance study. BJOG. 2017 Jan;124(1):79-86. doi: 10.1111/1471-0528.14053. Epub 2016 May 24.
PubMed 27219027Alberto C, Wagner N, Fougere Y, Meyer Sauteur PM, Scherler G, Aebbi-Popp K, Baumann M, Schobi N, Catho G, Emonet S, Polli C, Kottanattu L, Kahlert C, Baud D, Coste A, Martinez De Tejada B, Posfay Barbe KM, Toutous Trellu L. Syphilis in pregnant women and congenital syphilis from 2012 to 2021 in Switzerland: a multicentre, retrospective study. Swiss Med Wkly. 2024 Nov 1;154:3678. doi: 10.57187/s.3678.
PubMed 39509430
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Syphilis in Switzerland: a National Multicentric Retrospective Epidemiological Study
- ClinicalTrials.gov ID
- NCT05975502
- Acronym / sponsor ID
- Study 2022-01296
- Conditions
- Congenital Syphilis
- Keywords
- Congenital syphilis, pregnant women with syphilis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Fonds national Suisse
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 4 Aug 2023 (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 retrospective national epidemiological Swiss study was conducted to establish a real prevalence and description of congenital syphilis, and to better classify the reported congenital syphilis.
Maternal risk factors to contract syphilis (i.e. socio-demographic, cultural and clinical factors) were also evaluated, in order to focus on prevention of these targeted population.
Follow up of the children born from mother with syphilis during pregnancy, until age 6, was recorded to evaluate the risk of congenital syphilis following treatment of maternal syphilis.
Detailed description
We conducted an observational and descriptive retrospective multicentric national study in Switzerland of all pregnant women diagnosed with syphilis during their pregnancy and their babies from childbirth to age 6.
Retrospective clinical and biological data already collected in the patient's medical file from 2012 until 2021 were collected from pregnant women diagnosed with syphilis during their pregnancy and their babies from childbirth to age 6, in Swiss universities and cantonal hospitals.
Cases were collected through the computerized laboratory records by selecting all pregnant women with a positive TPHA / TPPA serology and children born to mothers who had syphilis diagnosed during pregnancy or / and with a positive TPHA / TPPA serology. Data collected included clinical information's, results of biological tests and imagery available from the hospital's internal archiving system and registered on two standardized coded case report forms (one for the mother and one for the babies).
Recent guidelines from the Centers for Disease Control recommend testing for syphilis at the first prenatal visit and again at 28 weeks gestation and at delivery if at high risk for syphilis acquisition during pregnancy. The identification, through the collection of epidemiological data, of risk factors for developing congenital syphilis during pregnancy may improve the prevention of congenital syphilis in the population at risk. It would make it possible to carry out preventive actions, repeated screening of syphilis during pregnancy and closer monitoring in a targeted population of women of childbearing age.
Thus, a proactive sentinel network could be developed to limit new cases of congenital syphilis in Switzerland, with the development of tools that could send alerts to the various specialists involved (biologist, gynaecologist, paediatrician, dermatologist) when a syphilis serology comes back positive in a pregnant woman.
This project is part of one of WHO's goals to eradicate congenital syphilis, as a better knowledge of congenital syphilis could lead us to propose solutions intended to reduce this serious disease. All the more that congenital syphilis is preventable by syphilis pregnancy screening and the burden of congenital syphilis is avoidable with a simple cost-effective treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with positive syphilis serology | – | Other: Epidemiological studyPregnant women with blood TPHA/TPPA ≥ 80 |
| Children born with positive syphilis serology | – | Other: Epidemiological studyChildren born from mothers with syphilis during pregnancy and / or with blood TPHA/TPPA ≥ 80 at birth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant women with a positive syphilis screening and their babies until age 6 from university and cantonal hospitals in Switzerland (Geneva, Lausanne, Zurich, Bern, Basel, Saint Gallen, Valais, Lugano) in dermatology, paediatric and gynaecology wards. Retrospective analysis of data from medical records.
Key inclusion criteria (2 listed)
- All pregnant women who had a positive TPHA / TPPA serology during pregnancy.
- All children born to mothers who had syphilis diagnosed during pregnancy or / and with a positive TPHA / TPPA serology.
Key exclusion criteria (1 listed)
- Document in the medical file attesting to a refusal of consent to the re-use of the data
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 |
|---|---|---|
| Epidemiological studyStudy of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy. | Other | Children born with positive syphilis serology, Pregnant women with positive syphilis serology |
Primary outcome
To quantify the number of syphilis cases during pregnancy and the number of congenital syphilis cases.
Time frame: Ten years: 2012 - 2021
Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.
To describe maternal characteristics associated with congenital syphilis (i.e. socio-demographic, cultural and clinical factors), in order to focus on prevention of these targeted population.
Time frame: Ten years: 2012 - 2021
Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.
1 secondary outcome
To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.
Time frame: Ten years: 2012 - 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Background: PubMed 34465590Kimball A, Bowen VB, Miele K, Weinstock H, Thorpe P, Bachmann L, McDonald R, Machefsky A, Torrone E. Congenital Syphilis Diagnosed Beyond the Neonatal Period in the United States: 2014-2018. Pediatrics. 2021 Sep;148(3):e2020049080. doi: 10.1542/peds.2020-049080.
- Background: PubMed 36376519Salome S, Cambriglia MD, Scarano SM, Capone E, Betts I, Pacella D, Sansone M, Mazzarelli LL, Lo Vecchio A, Ranucci G, Marinosci GZ, Capasso L, Salvatore P, Raimondi F. Congenital syphilis in the twenty-first century: an area-based study. Eur J Pediatr. 2023 Jan;182(1):41-51. doi: 10.1007/s00431-022-04703-5. Epub 2022 Nov 14.
- Background: PubMed 27219027Townsend CL, Francis K, Peckham CS, Tookey PA. Syphilis screening in pregnancy in the United Kingdom, 2010-2011: a national surveillance study. BJOG. 2017 Jan;124(1):79-86. doi: 10.1111/1471-0528.14053. Epub 2016 May 24.
- Derived from this study: PubMed 39509430Alberto C, Wagner N, Fougere Y, Meyer Sauteur PM, Scherler G, Aebbi-Popp K, Baumann M, Schobi N, Catho G, Emonet S, Polli C, Kottanattu L, Kahlert C, Baud D, Coste A, Martinez De Tejada B, Posfay Barbe KM, Toutous Trellu L. Syphilis in pregnant women and congenital syphilis from 2012 to 2021 in Switzerland: a multicentre, retrospective study. Swiss Med Wkly. 2024 Nov 1;154:3678. doi: 10.57187/s.3678.
- Syphilis and congenital syphilis in Europe - A review of epidemiological trends (2007-2018) and options for responseLink provided by the sponsor.
- World Health Organisation - Governance guidance for the validation of elimination of mother-to-child transmission of HIV and syphilisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Syphilis, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To quantify the number of syphilis cases during pregnancy and the number of congenital syphilis cases. (time frame: Ten years: 2012 - 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975502, which also lists 4 linked publications.
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 4 Aug 2023.