Congenital Syphilis in Switzerland

NCT ID: NCT05975502

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-19

Study Completion Date

2023-07-04

Brief Summary

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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

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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

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Congenital Syphilis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pregnant women with positive syphilis serology

Pregnant women with blood TPHA/TPPA ≥ 80

Epidemiological study

Intervention Type 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

Children born from mothers with syphilis during pregnancy and / or with blood TPHA/TPPA ≥ 80 at birth

Epidemiological study

Intervention Type OTHER

Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.

Interventions

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Epidemiological study

Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonds national Suisse

UNKNOWN

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Laurence Toutous Trellu

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laurence Toutous Trellu

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 34465590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36376519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27219027 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39509430 (View on PubMed)

Related Links

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https://www.ecdc.europa.eu/en/publications-data/syphilis-and-congenital-syphilis-europe-review-epidemiological-trends-2007-2018

Syphilis and congenital syphilis in Europe - A review of epidemiological trends (2007-2018) and options for response

https://www.who.int/publications-detail-redirect/governance-guidance-for-validation-of-emtct-syphilis-hiv

World Health Organisation - Governance guidance for the validation of elimination of mother-to-child transmission of HIV and syphilis

https://www.bag.admin.ch/bag/fr/home/zahlen-und-statistiken/zahlen-zu-infektionskrankheiten.html

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

Other Identifiers

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Study 2022-01296

Identifier Type: -

Identifier Source: org_study_id

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