Pregnancy and Congenital Toxoplasmosis

NCT ID: NCT05774496

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2024-03-16

Brief Summary

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.

Conditions

Congenital Toxoplasmosis; Retinochoroiditis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Congenital toxoplasmosis women

Women older than 21 suffering from congenital toxoplasmosis, with or without children.

Estimation of the occurrence of retinochoroiditis in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence) during pregnancy and postpartum.

Intervention Type: OTHER

All fundus examinations completed during pregnancy and postpartum in women with congenital toxoplasmosis and previous retinochoroiditis lesions are going to be checked.

Interventions

Estimation of the occurrence of retinochoroiditis in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence) during pregnancy and postpartum.

All fundus examinations completed during pregnancy and postpartum in women with congenital toxoplasmosis and previous retinochoroiditis lesions are going to be checked.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine Wallon

Role: PRINCIPAL_INVESTIGATOR

Service de parasitologie et mycologie médicale de l'Hôpital de la Croix-Rousse

Locations

Service de parasitologie et mycologie médicale

Lyon, , France

Countries

France

Other Identifiers

2022-A02496-37

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL22_1041

Identifier Type: -

Identifier Source: org_study_id