xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975502</url>
    </required_header>
    <id_info>
      <org_study_id>Study 2022-01296</org_study_id>
      <nct_id>NCT05975502</nct_id>
    </id_info>
    <brief_title>Congenital Syphilis in Switzerland</brief_title>
    <official_title>Congenital Syphilis in Switzerland: a National Multicentric Retrospective Epidemiological Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Geneva</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fonds national Suisse</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Geneva</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A retrospective national epidemiological Swiss study was conducted to establish a real&#xD;
        prevalence and description of congenital syphilis, and to better classify the reported&#xD;
        congenital syphilis.&#xD;
  &#xD;
        Maternal risk factors to contract syphilis (i.e. socio-demographic, cultural and clinical&#xD;
        factors) were also evaluated, in order to focus on prevention of these targeted population.&#xD;
  &#xD;
        Follow up of the children born from mother with syphilis during pregnancy, until age 6, was&#xD;
        recorded to evaluate the risk of congenital syphilis following treatment of maternal&#xD;
        syphilis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We conducted an observational and descriptive retrospective multicentric national study in&#xD;
        Switzerland of all pregnant women diagnosed with syphilis during their pregnancy and their&#xD;
        babies from childbirth to age 6.&#xD;
  &#xD;
        Retrospective clinical and biological data already collected in the patient's medical file&#xD;
        from 2012 until 2021 were collected from pregnant women diagnosed with syphilis during their&#xD;
        pregnancy and their babies from childbirth to age 6, in Swiss universities and cantonal&#xD;
        hospitals.&#xD;
  &#xD;
        Cases were collected through the computerized laboratory records by selecting all pregnant&#xD;
        women with a positive TPHA / TPPA serology and children born to mothers who had syphilis&#xD;
        diagnosed during pregnancy or / and with a positive TPHA / TPPA serology. Data collected&#xD;
        included clinical information's, results of biological tests and imagery available from the&#xD;
        hospital's internal archiving system and registered on two standardized coded case report&#xD;
        forms (one for the mother and one for the babies).&#xD;
  &#xD;
        Recent guidelines from the Centers for Disease Control recommend testing for syphilis at the&#xD;
        first prenatal visit and again at 28 weeks gestation and at delivery if at high risk for&#xD;
        syphilis acquisition during pregnancy. The identification, through the collection of&#xD;
        epidemiological data, of risk factors for developing congenital syphilis during pregnancy may&#xD;
        improve the prevention of congenital syphilis in the population at risk. It would make it&#xD;
        possible to carry out preventive actions, repeated screening of syphilis during pregnancy and&#xD;
        closer monitoring in a targeted population of women of childbearing age.&#xD;
  &#xD;
        Thus, a proactive sentinel network could be developed to limit new cases of congenital&#xD;
        syphilis in Switzerland, with the development of tools that could send alerts to the various&#xD;
        specialists involved (biologist, gynaecologist, paediatrician, dermatologist) when a syphilis&#xD;
        serology comes back positive in a pregnant woman.&#xD;
  &#xD;
        This project is part of one of WHO's goals to eradicate congenital syphilis, as a better&#xD;
        knowledge of congenital syphilis could lead us to propose solutions intended to reduce this&#xD;
        serious disease. All the more that congenital syphilis is preventable by syphilis pregnancy&#xD;
        screening and the burden of congenital syphilis is avoidable with a simple cost-effective&#xD;
        treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 19, 2022</start_date>
    <completion_date type="Actual">July 4, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To quantify the number of syphilis cases during pregnancy and the number of congenital syphilis cases.</measure>
      <time_frame>Ten years: 2012 - 2021</time_frame>
      <description>Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>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.</measure>
      <time_frame>Ten years: 2012 - 2021</time_frame>
      <description>Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.</measure>
      <time_frame>Ten years: 2012 - 2021</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">265</enrollment>
    <condition>Congenital Syphilis</condition>
    <arm_group>
      <arm_group_label>Pregnant women with positive syphilis serology</arm_group_label>
      <description>Pregnant women with blood TPHA/TPPA ≥ 80</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Children born with positive syphilis serology</arm_group_label>
      <description>Children born from mothers with syphilis during pregnancy and / or with blood TPHA/TPPA ≥ 80 at birth</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Epidemiological study</intervention_name>
      <description>Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.</description>
      <arm_group_label>Children born with positive syphilis serology</arm_group_label>
      <arm_group_label>Pregnant women with positive syphilis serology</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All pregnant women with a positive syphilis screening and their babies until age 6 from&#xD;
          university and cantonal hospitals in Switzerland (Geneva, Lausanne, Zurich, Bern, Basel,&#xD;
          Saint Gallen, Valais, Lugano) in dermatology, paediatric and gynaecology wards.&#xD;
  &#xD;
          Retrospective analysis of data from medical records.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All pregnant women who had a positive TPHA / TPPA serology during pregnancy.&#xD;
  &#xD;
            -  All children born to mothers who had syphilis diagnosed during pregnancy or / and with&#xD;
               a positive TPHA / TPPA serology.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Document in the medical file attesting to a refusal of consent to the re-use of the&#xD;
               data&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Laurence Toutous Trellu</name>
        <address>
          <city>Geneva</city>
          <zip>1204</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <link>
      <url>https://www.ecdc.europa.eu/en/publications-data/syphilis-and-congenital-syphilis-europe-review-epidemiological-trends-2007-2018</url>
      <description>Syphilis and congenital syphilis in Europe - A review of epidemiological trends (2007-2018) and options for response</description>
    </link>
    <link>
      <url>https://www.who.int/publications-detail-redirect/governance-guidance-for-validation-of-emtct-syphilis-hiv</url>
      <description>World Health Organisation - Governance guidance for the validation of elimination of mother-to-child transmission of HIV and syphilis</description>
    </link>
    <link>
      <url>https://www.bag.admin.ch/bag/fr/home/zahlen-und-statistiken/zahlen-zu-infektionskrankheiten.html</url>
      <description>Office fédéral de la santé publique. - Chiffres Maladies infectieuses - Syphilis</description>
    </link>
    <reference>
      <citation>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.</citation>
      <PMID>34465590</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36376519</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27219027</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
      <investigator_full_name>Laurence Toutous Trellu</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>Congenital syphilis</keyword>
    <keyword>pregnant women with syphilis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syphilis</mesh_term>
      <mesh_term>Syphilis, Congenital</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975502
  org study id: Study 2022-01296
  nct id: NCT05975502
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Retrospective
  measure: To quantify the number of syphilis cases during pregnancy and the number of congenital syphilis cases.
  time frame: Ten years: 2012 - 2021
  description: Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.
  measure: 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
  description: Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.
  measure: To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.
  time frame: Ten years: 2012 - 2021
  arm group label: Pregnant women with positive syphilis serology
  description: Pregnant women with blood TPHA/TPPA ≥ 80
  arm group label: Children born with positive syphilis serology
  description: Children born from mothers with syphilis during pregnancy and / or with blood TPHA/TPPA ≥ 80 at birth
  intervention type: Other
  intervention name: Epidemiological study
  description: Study of epidemiological characteristics of women with syphilis during pregnancy and of children born from mothers with syphilis during pregnancy.
  arm group label: Children born with positive syphilis serology
  arm group label: Pregnant women with positive syphilis serology
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Switzerland
  url: https://www.ecdc.europa.eu/en/publications-data/syphilis-and-congenital-syphilis-europe-review-epidemiological-trends-2007-2018
  description: Syphilis and congenital syphilis in Europe - A review of epidemiological trends (2007-2018) and options for response
  url: https://www.who.int/publications-detail-redirect/governance-guidance-for-validation-of-emtct-syphilis-hiv
  description: World Health Organisation - Governance guidance for the validation of elimination of mother-to-child transmission of HIV and syphilis
  url: https://www.bag.admin.ch/bag/fr/home/zahlen-und-statistiken/zahlen-zu-infektionskrankheiten.html
  description: Office fédéral de la santé publique. - Chiffres Maladies infectieuses - Syphilis
  citation: 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
  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.
  PMID: 36376519
  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.
  PMID: 27219027
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Geneva
  investigator full name: Laurence Toutous Trellu
  investigator title: Medical Doctor
  mesh term: Syphilis
  mesh term: Syphilis, Congenital
  sharing ipd: No