Congenital Syphilis in Switzerland

NCT05975502 | Completed

• 1 other identifier: Study 2022-01296
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Syphilis

Keywords

Congenital syphilis; pregnant women with syphilis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.

  Ten years: 2012 - 2021

Study Arms (2)

Pregnant women with positive syphilis serology

Pregnant women with blood TPHA/TPPA ≥ 80

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

Other: Epidemiological study

Interventions

Epidemiological study OTHER

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; Pregnant women with positive syphilis serology

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Fonds national Suisse: collaborator

Study Sites (1)

Laurence Toutous Trellu

Geneva, 1204, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 34465590 BACKGROUND

• 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.

  PMID: 36376519 BACKGROUND

• 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.

  PMID: 27219027 BACKGROUND

• Alberto 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.

  PMID: 39509430 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Syphilis, Congenital

Interventions

Epidemiologic Studies

Condition Hierarchy (Ancestors)

Syphilis; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: October 19, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 4, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)