Congenital Syphilis in Switzerland

Sponsor
University Hospital, Geneva (Other)
Overall Status
Completed
CT.gov ID
NCT05975502
Collaborator
Fonds national Suisse (Other)
265
1
8.5
31.3

Study Details

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 Phase
  • 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 :
Oct 19, 2022
Actual Primary Completion Date :
Jun 30, 2023
Actual Study Completion Date :
Jul 4, 2023

Arms and Interventions

Arm 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. [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. [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. [Ten years: 2012 - 2021]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Laurence Toutous Trellu Geneva Switzerland 1204

Sponsors and Collaborators

  • University Hospital, Geneva
  • Fonds national Suisse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Laurence Toutous Trellu, Medical Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT05975502
Other Study ID Numbers:
  • Study 2022-01296
First Posted:
Aug 4, 2023
Last Update Posted:
Aug 4, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
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, Medical Doctor, University Hospital, Geneva
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2023