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Completed

NCT Number: NCT05774496

Pregnancy and Congenital Toxoplasmosis

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: GRETA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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