Congenital Syphilis in Switzerland

• ClinicalTrials.gov Identifier: NCT05975502
• Recruitment Status: Completed
• First Posted: August 4, 2023
• Last Update Posted: August 4, 2023
• Sponsor: University Hospital, Geneva
• Collaborator: Fonds national Suisse
• Information provided by (Responsible Party): Laurence Toutous Trellu, University Hospital, Geneva

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Congenital Syphilis	Other: Epidemiological study

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

• Study Type: Observational
• Actual Enrollment: 265 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Congenital Syphilis in Switzerland: a National Multicentric Retrospective Epidemiological Study
• Actual Study Start Date: October 19, 2022
• Actual Primary Completion Date: June 30, 2023
• Actual Study Completion Date: July 4, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pregnant women with positive syphilis serology; Pregnant women with blood TPHA/TPPA ≥ 80	Other: Epidemiological study; Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.
Children born with positive syphilis serology; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. To describe the clinical itinerary, follow-up and development of their baby from birth to age 6. [ Time Frame: Ten years: 2012 - 2021 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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.

Criteria

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

Contacts and Locations

Locations

Switzerland

Laurence Toutous Trellu

Geneva, Switzerland, 1204

Sponsors and Collaborators

University Hospital, Geneva

Fonds national Suisse

More Information

Additional Information:

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 

Office fédéral de la santé publique. - Chiffres Maladies infectieuses - Syphilis 

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.

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.

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.

• Responsible Party: Laurence Toutous Trellu, Medical Doctor, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT05975502
• Other Study ID Numbers: Study 2022-01296
• First Posted: August 4, 2023
• Last Update Posted: August 4, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laurence Toutous Trellu, University Hospital, Geneva:

Congenital syphilis; pregnant women with syphilis

Additional relevant MeSH terms:

Syphilis; Syphilis, Congenital; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Infant, Newborn, Diseases