Pregnancy and Congenital Toxoplasmosis (GRETA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Toxoplasmosis; Retinochoroiditis
• Intervention / Treatment: Other: Estimation of the occurrence of retinochoroiditis in women with congenital toxoplasmosis and previous retinochoroiditis lesions (recurrence) during pregnancy and postpartum.

• Study Type: Observational
• Enrollment (Anticipated): 193

Contacts and Locations

• Study Contact: Name: Martine Wallon, MD,PhD,PUPH; Phone Number: +33 4 72 00 37 44; Email: martine.wallon@chu-lyon.fr
• Study Contact Backup: Name: Justine Sales, MSc Student; Email: justine.sales@etu.univ-lyon1.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Service de parasitologie et mycologie médicale
    • Contact: Martine Wallon; Phone Number: 04.72.00.37.44; Email: martine.wallon@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The Lyon cohort is composed of 193 women suffering from a congenital toxoplasmosis confirmed at their birth in the parasitology and mycology unit of the La Croix-Rousse hospital, and they have been tracked since then.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Infant, Newborn, Diseases; Central Nervous System Infections; Parasitic Diseases; Coccidiosis; Protozoan Infections; Central Nervous System Parasitic Infections; Central Nervous System Protozoal Infections; Toxoplasmosis; Toxoplasmosis, Congenital
• Other Study ID Numbers: 69HCL22_1041; 2022-A02496-37 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No