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临床试验/NCT05975502
NCT05975502已完成不适用

Congenital Syphilis in Switzerland: a National Multicentric Retrospective Epidemiological Study

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2022年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
265
试验地点
1
主要终点
To quantify the number of syphilis cases during pregnancy and the number of congenital syphilis cases.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

To quantify the number of syphilis cases during pregnancy and the number of congenital syphilis cases.

时间窗: Ten years: 2012 - 2021

Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.

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.

时间窗: Ten years: 2012 - 2021

Study of medical records of all university hospitals in Switzerland through a national observational epidemiological study from 2012 until now.

次要结局

  • To describe the clinical itinerary, follow-up and development of their baby from birth to age 6.(Ten years: 2012 - 2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurence Toutous Trellu

Medical Doctor

University Hospital, Geneva

研究点 (1)

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