Pregnancy and Congenital Toxoplasmosis

Congenital Toxoplasmosis Clinical Trial

— GRETA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774496
• Other study ID #: 69HCL22_1041
• Secondary ID: 2022-A02496-37
• Status: Recruiting
• Start date: May 10, 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Hospices Civils de Lyon
• Contact: Martine Wallon, MD,PhD,PUPH
• Phone: 4 72 00 37 44
• Email: martine.wallon[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 193
• Est. completion date: May 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Toxoplasmosis
• Toxoplasmosis
• Toxoplasmosis, Congenital

Intervention

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.

Locations

Country	Name	City	State
France	Service de parasitologie et mycologie médicale	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of toxoplasmic retinochoroiditis during pregnancy in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence).	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.	Toxoplasmic retinochoroiditis that occured during pregnancy (up to 40 weeks)
Primary	The number of toxoplasmic retinochoroiditis during postpartum in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence).	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.	Toxoplasmic retinochoroiditis that occured during postpartum (up to 6 months after the delivery)