An observational study in Congenital Syphilis, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2023-08-04.
Sponsored by University Hospital, Geneva · Observational
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.
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.
120 studies on the registry are indexed under Syphilis; 33 are open to participants now.
This study's enrollment of 265 is below the median of 356 across 36 observational studies indexed under Syphilis.
Browse Syphilis studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Pregnant women with blood TPHA/TPPA ≥ 80
Other: Epidemiological study
Children born from mothers with syphilis during pregnancy and / or with blood TPHA/TPPA ≥ 80 at birth
Other: Epidemiological study
Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.
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.
Time frame: 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.
Time frame: Ten years: 2012 - 2021
To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.
Time frame: Ten years: 2012 - 2021
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva