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临床试验/NCT05774496
NCT05774496已完成不适用

Pregnancy and Congenital Toxoplasmosis : Maternal and Child Risks Assessment, Data From Patients Followed-up in the Lyon Cohort

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年5月10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
76
试验地点
1
主要终点
The number of toxoplasmic retinochoroiditis during pregnancy in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence).

研究概览

简要总结

The Toxoplasma gondii parasite causes toxoplasmosis. It is characterized by persistent cysts mostly localised in the brain and ocular areas. In the case of immunodeficiency, those cysts are likely to reactivate. During pregnancy, an infection exposes the foetus to a variety of consequences, from severe neurologic lesions to subclinical forms at birth. However, those forms are likely to complicate at any age to toxoplasmic retinochoroiditis, that can unpredictably recur with severe functional consequences. Pregnancy may stimulate lesions or their recurrences, putting the foetus at risk of contamination because of the release of tachyzoites in the bloodstream. The occurrence of these complications is poorly known, especially with congenital toxoplasmosis. Nevertheless, this information is essential to take care of patients, particularly women with congenital toxoplasmosis, usually worried about the consequences of a pregnancy.

As a precaution, women with congenital toxoplasmosis follow a specific ophthalmologic, and trimonthly monitoring, composed of fundus examinations during pregnancy and in postpartum. To eliminate the contamination risk, serological examinations at birth and one year later are done on their kids.

The aim of this study is to estimate the risk of toxoplasmic retinochoroiditis during pregnancy and the impact on their children. Retrospective and prospective data from the Lyon Cohort of Maternal and Congenital Toxoplasma Infections will be used.

As a result of to this study, the investigators expect to provide better information to women suffering from congenital toxoplasmosis about their own ocular safety during pregnancy, and the safety of their child(ren). The investigators seek to provide new national and international recommendations about these patients and their children's care.

研究设计

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

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being a woman
  • Born before March 2022
  • Suffering from congenital toxoplamosis

排除标准

  • Refusal to give informed consent
  • Any condition that would limit the ability of the patient to give consent
  • Psychiatric cares
  • To be deprived of liberty
  • To be under administrative supervision

结局指标

主要结局

The number of toxoplasmic retinochoroiditis during pregnancy in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence).

时间窗: Toxoplasmic retinochoroiditis that occured during pregnancy (up to 40 weeks)

All fundus examinations completed during pregnancy in women with congenital toxoplasmosis and previous retinochoroiditis lesions are going to be checked. The occurrence of retinochoroiditis during pregnancy will be compared to the occurrence of toxoplasmic retinochoroiditis during periods without pregnancy.

The number of toxoplasmic retinochoroiditis during postpartum in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence).

时间窗: Toxoplasmic retinochoroiditis that occured during postpartum (up to 6 months after the delivery)

All fundus examinations completed during postpartum in women with congenital toxoplasmosis and previous retinochoroiditis lesions are going to be checked. The occurrence of retinochoroiditis during postpartum will be compared to the occurrence of toxoplasmic retinochoroiditis during periods without pregnancy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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