Congenital Syphilis in Switzerland

Congenital Syphilis Clinical Trial

Official title:

Congenital Syphilis in Switzerland: a National Multicentric Retrospective Epidemiological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05975502
• Other study ID #: Study 2022-01296
• Status: Completed
• Start date: October 19, 2022
• Est. completion date: July 4, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: July 4, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Document in the medical file attesting to a refusal of consent to the re-use of the data

Related Conditions & MeSH terms

• Congenital Syphilis
• Syphilis
• Syphilis, Congenital

Intervention

Other:
• Epidemiological study
Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.

Locations

Country	Name	City	State
Switzerland	Laurence Toutous Trellu	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Fonds national Suisse

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

Salome 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. — View Citation

Townsend 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Ten years: 2012 - 2021
Primary	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.	Ten years: 2012 - 2021
Secondary	To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.		Ten years: 2012 - 2021

External Links

•   Office fédéral de la santé publique. - Chiffres Maladies infectieuses - Syphilis
•   Syphilis and congenital syphilis in Europe - A review of epidemiological trends (2007-2018) and options for response
•   World Health Organisation - Governance guidance for the validation of elimination of mother-to-child transmission of HIV and syphilis