GRETA: Pregnancy and Congenital Toxoplasmosis

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05774496
• Collaborator: (none)
• Enrollment: 193
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Toxoplasmosis; Retinochoroiditis	Other: Estimation of the occurrence of retinochoroiditis in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence) during pregnancy and postpartum.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 193 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Pregnancy and Congenital Toxoplasmosis : Maternal and Child Risks Assessment, Data From Patients Followed-up in the Lyon Cohort
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Congenital toxoplasmosis women Women older than 21 suffering from congenital toxoplasmosis, with or without children.	Other: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Martine Wallon, Service de parasitologie et mycologie médicale de l'Hôpital de la Croix-Rousse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT05774496
• Other Study ID Numbers: 69HCL22_1041; 2022-A02496-37
• First Posted: Mar 17, 2023
• Last Update Posted: Mar 17, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Toxoplasmosis; Toxoplasmosis, Congenital

Study Results

No Results Posted as of Mar 17, 2023